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Successful Treatment of a Venous Leg Ulcer With Manuka Honey: A Case Study

Affiliations.

  • 1 Diego Gabriel Mosteiro-Miguéns, Badalona Serveis Assistencials (BSA), Health Care Centre of Morera-Pomar, Badalona, Barcelona, Spain.
  • 2 Cristina Herrera-Jiménez, Badalona Serveis Assistencials (BSA), Health Care Centre of Morera-Pomar, Badalona, Barcelona, Spain.
  • 3 Héctor Lorenzo-Ruiz, Badalona Serveis Assistencials (BSA), Health Care Centre of Morera-Pomar, Badalona, Barcelona, Spain.
  • 4 Eva María Domínguez-Martís, Master in Health Care, Management and Care, Galician Public Health Care Service, Health Care Centre of Concepción Arenal, Santiago de Compostela, A Coruña, Spain.
  • 5 Silvia Novío, Doctor of Dental Medicine, Department of Psychiatry, Radiology, Public Health, Nursing and Medicine, Faculty of Nursing, University of Santiago de Compostela, Santiago de Compostela, A Coruña, Spain.
  • PMID: 33427815
  • DOI: 10.1097/WON.0000000000000712

Background: Refractory venous leg ulcers (VLUs) often require extended time to heal, and they carry a high risk of recurrence. This case study describes our experiences with a patient with a VLU refractory to multiple treatment strategies who was successfully treated with Manuka honey.

Case: Mr S. was a 76-year-old man with multiple comorbid conditions and hypersensitivity to silver-based compounds, who developed 3 VLUs of his right lower extremity. He experienced 90 days of unsuccessful treatments using an iodized cadexomer ointment, hydrodetersive fiber dressings, hydrocolloid meshes, compression therapy, and antibiotic treatment without progression toward wound healing. We then initiated treatment with Manuka honey and continued compression therapy. His primary VLU was completely epithelialized within 38 days, and an adjacent VLU also showed progression toward healing. Mr S. reported clinically relevant improvement in wound-related pain at 17 days.

Conclusion: The use of Manuka honey proved effective in this patient with a VLU refractory to other treatment strategies.

Copyright © 2021 by the Wound, Ostomy and Continence Nurses Society.

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Conflict of interest statement

The authors declare no conflicts of interest and no source of funding.

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  • Antibiotics and antiseptics for venous leg ulcers. O'Meara S, Al-Kurdi D, Ologun Y, Ovington LG, Martyn-St James M, Richardson R. O'Meara S, et al. Cochrane Database Syst Rev. 2013 Dec 23;(12):CD003557. doi: 10.1002/14651858.CD003557.pub4. Cochrane Database Syst Rev. 2013. Update in: Cochrane Database Syst Rev. 2014 Jan 10;(1):CD003557. doi: 10.1002/14651858.CD003557.pub5. PMID: 24363048 Updated. Review.
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  • Oral aspirin for treating venous leg ulcers. de Oliveira Carvalho PE, Magolbo NG, De Aquino RF, Weller CD. de Oliveira Carvalho PE, et al. Cochrane Database Syst Rev. 2016 Feb 18;2(2):CD009432. doi: 10.1002/14651858.CD009432.pub2. Cochrane Database Syst Rev. 2016. PMID: 26889740 Free PMC article. Review.
  • A Meta-analysis to Compare Four-layer to Short-stretch Compression Bandaging for Venous Leg Ulcer Healing. De Carvalho MR, Peixoto BU, Silveira IA, Oliveria BGRB. De Carvalho MR, et al. Ostomy Wound Manage. 2018 May;64(5):30-37. Ostomy Wound Manage. 2018. PMID: 29847309 Review.
  • Clinical and cost efficacy of advanced wound care matrices for venous ulcers. Hankin CS, Knispel J, Lopes M, Bronstone A, Maus E. Hankin CS, et al. J Manag Care Pharm. 2012 Jun;18(5):375-84. doi: 10.18553/jmcp.2012.18.5.375. J Manag Care Pharm. 2012. PMID: 22663170 Free PMC article. Review.
  • Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2014;130:333–346.
  • Scottish Intercollegiate Guidelines Network. Management of Chronic Venous Leg Ulcers. Edinburgh, England: SIGN; 2010.
  • Abbade LP, Lastória S. Venous ulcer: epidemiology, physiopathology, diagnosis and treatment. Int J Dermatol. 2005;44(4):449–456.
  • Kelechi T, Brunette G, Bonham PA, Crestodina L, Droste LR, Ratliff CR. 2019 Guideline for management of wounds in patients with lower-extremity venous disease (LEVD): an executive summary. J Wound Ostomy Continence Nurs. 2020;47(2):97–110.
  • Melikian R, O'Donnell TF, Suarez L, Iafrati MD. Risk factors associated with the venous leg ulcer that fails to heal after 1 year of treatment. J Vasc Surg Venous Lymphat Disord. 2019;7(1):98–105.

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Diagnosis and management of venous leg ulcers

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  • Chung Sim Lim , consultant vascular and endovascular surgeon 1 ,
  • Moushumi Baruah , general practitioner (partner) 2 ,
  • Sandeep S Bahia , consultant vascular and endovascular surgeon 3
  • 1 Department of Vascular Surgery, Royal Free London NHS Foundation Trust, London NW3 2QG, UK
  • 2 Burney Street Practice, Greenwich, London SE10 8EX, UK
  • 3 St George’s Vascular Institute, St George’s University Hospitals NHS Foundation Trust, London SW17 0QT, UK
  • Correspondence to: C S Lim cslim{at}doctors.org.uk

What you need to know

Venous leg ulcers are the most severe manifestations of chronic venous disease caused by venous hypertension

The mainstay of treatment is compression bandaging, which promotes healing and reduces recurrence by improving venous and lymphatic return, microcirculation and inflammation

Offer early referral to vascular specialists for ulcers that have not healed within two weeks of treatment or that recur

Early endovenous ablation of superficial venous reflux promotes healing of venous leg ulcers

Compression hosiery, good skin care, and a vascular service assessment for surgery for superficial venous reflux help to reduce ulcer recurrence

Venous leg ulcers are the most common type of leg ulcer, with an estimated prevalence of 0.1 and 0.3% in the UK. 1 The lifetime risk of developing a venous leg ulcer is 1%. 2 3 A recent retrospective cohort study using THIN (The Health Improvement Network) data reported that in the UK 53% of all venous leg ulcers healed within 12 months, with a mean healing time of three months. 4 Service provision in the UK for venous leg ulcers can be poor, with around half of patients receiving inadequate care, minimal specialist involvement, and lack of evidence-based treatment according to GP records. 4 5 Similar significant evidence-practice gap has been reported around the world including in several developed countries. 6 7 8 This clinical update, aimed at non-specialists, provides information on the diagnosis and management of venous leg ulcers, and offers multidisciplinary team support.

Sources and selection criteria

We searched PubMed using the terms “venous ulcer” and “compression therapy,” giving particular attention to meta-analyses and systematic reviews, including those from the Cochrane database, and guidelines from major international and national organisations and societies with an interest in venous ulcers. We also looked for publications in nursing journals to explore the up-to-date holistic approach in the diagnosis and management of venous …

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venous leg ulcer case study essay

venous leg ulcer case study essay

Volume 27 Number 2

Getting lower leg ulcer evidence into primary health care nursing practice: a case study.

Sue Randall, Panagiota Avramidis, Naomi James, Alanda Vincent, Rebecca Armstrong and Michelle Barakat-Johnson

Keywords Audit, community nursing, evidence-based practice, nurse-led, venous leg ulcers.

For referencing Randall S et al. Getting lower leg ulcer evidence into primary health care nursing practice: a case study. WP&R Journal 2019; 27(2):78-85.

DOI https://doi.org/10.33235/wpr.27.2.78-85

Venous leg ulcers (VLUs) are open lesions on the lower leg caused by venous disease, which are associated with high morbidity and pose a challenge to manage effectively (Scottish Intercollegiate Guidelines Network, 2010). Gold standard treatment for VLUs is graduated compression therapy to aid venous return. This paper presents an approach to the challenging management of VLUs that is based on a problem, and subsequent local audit. We use a case study that illustrates a collaborative approach to determine gaps in evidence-based practice (EBP), and a nurse-led initiative in consultation with executive managers and doctors. In our sample, 40% of patients had not consulted a vascular specialist. They did not have a formal diagnosis of leg ulcer aetiology and therefore had not received optimum treatment. Access and cost were main factors impacting on leg ulcer care. Nurses providing evidence-based management of VLUs should ensure collaboration with key stakeholders. This assists in implementing diagnosis of ulcer aetiology for best practice measures. At this local health district, a change in policy to reflect EBP for VLU management in primary health care has been achieved.

What is already known

  • Evidence-based wound practice is an approach to patient care that integrates current information from research and local data, the expertise of clinicians and patient factors.
  • VLUs are a common wound in primary health care that pose significant issues for the patient, caregivers, nurses and specialists.
  • Graduated compression therapy is the ‘gold standard’ treatment for VLUs.

What this manuscript contributes

  • Best practice VLU care in primary health care is impeded by a number of factors, including cost, access to specialist medical consultation and primary health care resources.
  • A collaborative project by primary health care wound specialist nurses, an academic and a summer scholar, with time and expertise to undertake a project to investigate and address a problem, ultimately improved the quality of patient care.
  • A hand-held Doppler should be available to wound specialist nurses in primary health care to aid assessment and management of venous leg ulcers.

Introduction

Venous leg ulcers (VLUs) are defined as an open lesion between the knee and ankle joint, that remains unhealed and occurs in the presence of venous disease 1,p.1 . VLUs are chronic and reoccurring wounds caused by venous valve incompetence 2 . VLUs are the most common ulcer presentation in primary health care 3 .

The incidence of VLUs increases with age, between 1.5 and 3/1000 people aged 65 and below and increasing to 20/1000 people over age 85 3 . With an ageing population, the prevalence of VLUs has the potential to be greater 4-6 . Such an increase presents challenges to both patients and clinicians.

Chronic wounds cause considerable financial impact on health services, with costs crudely estimated as A$2 billion in Australia 7 and between £168 and 600 million in the United Kingdom 8 . Specifically, for chronic lower leg ulcers, estimated management costs are 6.5–7 million euros/year in Ireland alone 9 .

Assessment of any ulcer and accurate diagnosis of aetiology is critical to developing a management plan that achieves optimum outcomes for patients. Efforts should focus on developing strategies to identify, assess and ensure nursing practice and treatment is underpinned by evidence 10 in order to provide better value care.

VLUs impact considerably on patients and cause a substantial health burden. The impact on patients include symptoms for the patient, described as ‘pain-fatigue cluster’, comprising fatigue, sleep disturbance, depression and pain in the legs; and secondly, ‘inflammation cluster’, comprising fatigue, swelling, inflammation of the legs and exudate from ulcers 11 . Together these symptoms cause reduced quality of life (QoL) 14 . Individuals experience pain 12 and have restricted mobility 13 . They may become socially isolated, with a high incidence of anxiety and depression 13,14 . Personal financial costs are also described 15 . Recurrence of VLUs presents a significant challenge. VLU recurrence in one study in Australia involving 67 participants was 44% at 12 months with median breakdown at 27 weeks 14 . Recurrence from 52% to as high as 70% in international studies have been reported 12,16,17 .

The care of patients with VLUs presents a challenge for clinicians, creating a substantial workload for nurses that is physically demanding. For example, two nurses are often required to provide wound care: one nurse to hold the patient’s leg whilst the other nurse undertakes the dressing. Often this is because the patient’s legs are too heavy for them, or the nurses to lift, commonly due to oedema. As well as physical demands, Posnett et al. 8 state that a considerable emotional burden falls on nurses, particularly when wounds such as VLUs are slow or fail to heal. Nurses who provide wound management for patients with VLUs may feel a sense of hopelessness due to slow healing, despite wound management strategies. They may also feel less optimistic and less confident in their approach to leg ulcer care 18,19 .

VLUs can be assessed and managed by nurses in a variety of primary health care (PHC) settings, in specialist wound, vascular or leg clinics and leg clubs (evidence-based community clinics treating patients with leg ulcers) 20,21 . In a recent systematic review of 17 studies, the impact of Leg Clubs on patients, despite variable study quality, noted positive outcomes on the individual’s mood, sleep and quality of life. Faster healing and less recurrence of leg ulcers were also described 22 .

Ankle brachial pressure index (ABPI) measurement and graduated compression therapy are two key evidence-based measures in VLU care. ABPI is a non-invasive vascular screening test that can be carried out with a hand-held Doppler to exclude peripheral arterial disease (PAD) (a vascular condition due to narrowed arteries and associated with high morbidity and mortality) by comparing systolic blood pressures in the ankle to the higher of the brachial systolic blood pressures 23 . The ABPI value determines the severity of PAD, which guides best assessment, and management of VLUs. For example, an ABPI of between 0.8 and 1.2 means that therapeutic graduated compression therapy of the legs is needed, whereas an ABPI of less than 0.5 indicates that graduated compression therapy should be avoided and urgent specialist review is required. For ABPI between 0.5 and 0.8 caution is required and specialist review should be recommended 24 . If PAD has been excluded and venous aetiology is confirmed, then graduated compression therapy is the gold standard treatment for VLUs known to improve healing rates 12,25 .

VLU guidelines clearly state that appropriately trained clinicians can undertake ABPI measurements and apply graduated compression therapy 1,25-28 . The ABPI has high sensitivity and specificity and its accuracy in establishing the diagnosis of PAD has been well supported 29 . However, the implementation of this as part of best practice of VLU management can be challenged by shortage of resources, both a lack of knowledge of best practice and how to identify and address a gap in practice 30-32 . Implementing evidence into practice has been reported to take between eight and 30 years 33 . This time lag can result in gaps in clinical care.

In this paper, we use a case study approach to describe a collaborative of PHC nurses specialising in wounds, an academic and a summer scholar (a pre-registration nursing student on a scholarship to gain research experience) in one Australian local health district (LHD). They combined time and expertise to undertake a project which confirmed a gap in evidence-based practice (EBP). This paper also describes the robust response to the findings by managers in the LHD.

The LHD is in a high-density, inner-city district that contains three acute public hospitals, one sub-acute public hospital, and five PHC centres, with a large, diverse population of almost 700,000 people 34 . The PHC nursing team, which is spread across five geographically located PHC centres, had one consultant nurse and two nurses with specific interest and expertise in wound management. In this paper, they are communally referred to as wound specialist nurses (WSNs). In February 2017, this PHC nursing team had 596 existing patients. During the study period, an additional 418 new registrations resulted in a caseload of 1014 patients. Of these, 248 existing patients had chronic leg ulceration and a further 36 new admissions with lower leg ulcers (LLU) comprising 26% of the whole PHC nursing caseload 35 .

Of the audited patients (n=96) seen by the LHD WSNs, 62 patients had a leg ulcer that has either been recurrent or that lasted for multiple years. Visits made to the audited cohort of patients ranged from 1 to 328 visits, with average length of visit by nurses ranging from 5 to 80 minutes. All patients in the LHD were required to have a vascular specialist doctor review to confirm diagnosis of VLU and to confirm suitability for graduated compression therapy 29 . The LHD policy did not include WSNs to perform an ABPI, nor initiate graduated compression therapy 36 . The WSNs believed this was not in line with best evidence. Before reviewing the LHD policy, the WSNs wanted evidence that included current literature and local data on management of patients with VLU.

Claudia is a 69-year-old female with bilateral chronic leg ulcers of undiagnosed aetiology (Figure 1) and unmanaged exudate. Claudia is on the pension (a regular nominal payment made by the Australian Government to people of retirement age), has no family support and had reduced mobility due to her leg ulcers, further compounded by several steps to the entrance of her house, which she was unable to navigate. She had good pedal pulses and bilateral leg oedema that was suspected to be due to venous insufficiency.

Claudia required two registered nurses for each visit to provide treatment. She had two visits per week of approximately 30 minutes per visit. These visits were over a period of eight months, with the PHC nursing team maintaining, but not actively treating her ulcers. Although venous insufficiency was the likely cause of her ulcers, she had been unable to access the vascular specialist, and the aetiology of her ulcer had not been confirmed. Hence an inability to commence graduated compression therapy under the current LHD policy. Her leg ulcers often required expensive antimicrobial dressings due to recurrent ulcer infections. Her ulcers could have healed in a shorter period of time should she have been able to have ABPI assessment and commence graduated compression therapy. In Australia, the cost of a vascular specialist appointment is A$150–300, depending on required investigations and ongoing treatment. For Claudia, this was an impossible cost being on the pension. In this LHD, there is no cost to the patient for either nursing visits or dressings.

In addition to the cost, immobility and other factors significantly impeded Claudia’s ability to attend her other appointments, such as physiotherapy and occupational therapy. Other factors included the oedema in Claudia’s legs and the exudate from her ulcers, known as “heavy legs”. The nursing team would often arrange community transport for her to attend appointments, but without reducing the exudate, Claudia could not attend any appointments. Claudia was faced with multiple barriers to best practice: immobility, the cost of vascular specialist and social isolation. Claudia’s QoL was reduced, and her ulcers remained unhealed.

Collaboration with wound specialist nurses and academics

Concern was expressed by the WSNs about Claudia's unconfirmed diagnosis and sub-optimal treatment, so the collaborative undertook a project. The aim was to establish the evidence base and “a clear picture” of the current state of VLU practice in the LHD. The stages of the project included: 1) preparing for an audit; 2) literature review of best available evidence; 3) audit data to determine the evidence–practice gap; 4) making improvements; and 5) sustaining the change.

Stage 1: Conducting a case note audit

Stage 1 consisted of an audit. The audit had received research ethics approval (AU/6/6B6C25) and was carried out in accordance with the Declaration of Helsinki requirements 37 . In stage 1, it was important to identify the problem. In this example, Claudia’s current challenge included multiple barriers to best practice VLU management, such as immobility, no confirmed diagnosis, her inability to attend physiotherapy and occupational therapy, and social isolation, all leading to poor QoL.

Stage 2: Literature review of best available evidence

In stage 2, we determined what would be measured and what VLU “gold standards” were available to inform EBP and to add clarity and transferability. A search and review of the literature on VLU guidelines was undertaken. The databases searched were CINAHL, PubMed, Medline and Cochrane Library, and grey literature such as professional association websites. Search terms included nursing assessment, Doppler, ABPI and venous leg ulcer. This enabled the collaborative to ascertain best practice. To enable an overview of developing best practice leg ulcer care, no date limits were applied. Some VLU guidelines were found in the search; others were found through specialist nurse knowledge or through professional association websites (Table 1).

Table 1: Published guidelines for assessment and management of chronic leg ulcers (2010–2017)

randall table1.jpg

Stage 3: Determining the evidence–practice gap

In order to determine the evidence–practice gap in the LHD we collected data from a simple case note audit and compared LHD performance with the VLU guidelines and best practice literature from stage 2. Data were collected from the electronic medical records (eMR). The audit tool had questions relating to demographics such as age and sex; VLU history, recurrence, and time on caseload; wound details; total nursing time in minutes; ulcer type, nicotine history, diet, history of deep vein thrombosis (as a pre-disposing factor); co-morbidities; English as first language (which has the potential to impact on understanding medical terminology); pensioner or health care card holder; whether seen by a vascular specialist; living alone or housebound; pre-disposing risk factors; and social factors. This tool was developed by the WSN and pilot-tested on the records of five patients to see if the required information could be extracted from the eMR. Information that could not be found in the eMR was removed from the tool. These variables were selected because they provided context to the clinical picture of patients with LLUs as well as direct information to help address the practice gap. The authors wanted to ensure a standardised approach to auditing to increase rigour 38 . Therefore, every fourth set of case notes was audited. The ‘snapshot’ audit took place in July 2017, examining patient records who were on the caseload in February 2017. Data were entered into SPSS 20 and descriptive statistical analysis was undertaken.

Findings from the audit: An audit on patients with a lower leg ulcers was undertaken. Undertaking the audit in a PHC setting offered a profile of these patients in the LHD that included prevalence. Ninety-six sets of notes were audited. This represented a quarter of eligible case notes. Of the PHC caseload in February 2017, 28% comprised patients with LLUs and in line with existing literature, the majority (86%) of those with a diagnosis had venous ulcers 39 .

Pre-audit, the process for diagnosis of VLU aetiology in this LHD was through a doctor, nurse practitioner (NP) or a vascular specialist. For patients living in their own homes, a vascular specialist review was conducted in private consulting rooms. The cost for this review could vary in excess of A$200 which meant that for people like Claudia, many patients were unable to pay. Like Claudia, several patients (36/96) were also housebound or had limited means of transport, making access difficult. Our LHD policy did not cover WSNs to undertake ABPI, nor initiate graduated compression therapy 36 .

The data demonstrated a gap in evidence-based care. Of the 96 cases audited, 36 patients were new admissions so were removed from the audit, as they may not have had time to access a vascular specialist. Of the remaining, 60 patients, 40% (24/60) had not accessed a vascular specialist (Figure 2). These patients did not have a formal diagnosis of leg ulcer aetiology and hence did not receive the gold standard VLU treatment, that is, graduated compression therapy 27,40 . Of patients with LLUs who had not accessed a vascular specialist, 66% (40/60) were on a pension. This was statistically significant (p<0.001) and highlighted reduced equity and access. Analysing this data further, centres with patients of lower socio-economic status accessed specialist review least.

randall fig 2.jpg

The audit highlighted further influences on care. The number of existing patients who had accessed a vascular specialist was influenced by the primary health care nurse role. Patients were more likely to have accessed a vascular specialist if they had been reviewed by a WSN rather than a registered nurse (p=0.008) (Figure 3).

randall fig 3.jpg

Stage 4: Making improvements

The fourth stage of this project explored making improvements by implementing EBP. Results from the audit highlighted a gap in evidence-based care due to lack of access to vascular specialist. The findings were presented at a quality and research conference. This conference had approximately 100 nurse and executive delegates. A report of the findings 35 , which compared this LHD results and best practice national and international guidelines, was subsequently disseminated to the management team of PHC services. The WSNs prepared a submission to executive managers to secure funding for three Dopplers to aid assessment of housebound clients such as Claudia. For management of VLUs and improvements in service delivery, changes were made to the LHD policy on "Graduated Therapy Compression in Venous Disease", to allow WSNs to assess and authorise graduated compression therapy 41 .

The WSNs collaborated with the local vascular specialist doctor to discuss ways to improve the service for patients with VLUs in the community. A free LLU clinic in one PHC centre with bulk-billing services is planned. Bulk billing means that patients do not have to pay a fee for consultation as the payment is met through Medicare (publicly funded by the Australian Government).

Stage 5: Sustaining change

Stage 5 ensured the improvements we made in the LHD were going to be sustained. An annual audit will be conducted by the WSNs. A repeat audit is planned for February 2020. This audit and ongoing audits will be conducted by the collaborative to assess the impact of changes on practice and outcomes for people like Claudia who had been receiving sub-optimal treatment.

This paper presented a staged approach to establishing best available evidence and treatment options for patients with VLUs. Findings from our approach confirm that challenges of translating best evidence into practice can be overcome by auditing, exploring current research and working in collaboration. Establishing evidence, prior to implementing strategies is key to maximising outcomes for patients. Further, our team used a collaborative approach with nurses, student nurses and academics to identify and address the evidence–practice gap.

An audit provided data, which led to greater understanding of a problem and provided opportunities to resolve a gap in practice with the potential to improve the quality of care, in part by applying the PHC principles of equity and access 41-44 . Results highlighted a lack of diagnosis of leg ulcer aetiology, resulting in sub-optimal treatment of patients with VLUs. Across all five centres, there was an inequity for patients who were receiving a pension, as they were less likely to have accessed a vascular specialist, due to financial constraints. This led to sub-optimal treatment when measured against national and international guidelines.

This study was presented by the WSNs to the LHD executive team, which led to discussions with management and vascular doctors about the ability of WSNs to diagnose ulcer aetiology. In line with the VLU guidelines 1,25-28 , WSNs have the skills and knowledge to assess and manage VLUs. This would potentially improve the standard of care for patients with VLUs in the PHC and bring the issues of both equity and access in line with the World Health Organization principles of PHC 42-44 .

PHC focuses on integrated care that is accessible to all patients, is socially acceptable, evidence-based, and provided by a suitably qualified workforce 45 . PHC promotes independence at a personal and community level, striving to address and minimise issues regarding inequality while supporting those with the greatest need. This is achieved through collaboration across health sectors 45 . Undertaking this study has facilitated a greater collaboration between services, underpinned by guiding principles of equity, access, empowerment, self-determinism and inter-sectoral collaboration, improving outcomes for patients with VLUs. Collaboration between hospital, PHC and the university is seen as improving both patient experience and treatment for VLUs 46 .

Furthermore, in this study we found that patients were much more likely to have consulted a vascular specialist if they had been seen by a WSN. In this LHD, there is currently no direct referral process for a patient in primary health care to see a vascular specialist. The positive impact on patient outcomes from the combination of expertise of a vascular specialist and advanced nurse, such as the WSN involvement is safe, acceptable, cost-neutral and contributes to improving the patient and family experience 47 . Tsiachristas et al. 48 report that advanced NP roles such as WSNs improve access to care, provide patient information, increase satisfaction of patients and relatives, all leading to positive clinical outcomes, improved quality of care and health care utilisation. However, advanced nursing roles, such as WSNs may be impeded by a lack of clarity in boundaries and levels of practice which are, at times, individually and contextually constructed 49 , and as such, are an untapped health care resource 50 . Under-diagnosis, as noted in this audit, could be rectified by a protocol based on national and international guidelines. EBP results in both a reduction in health care costs and better patient outcomes 51 .

Staff engagement and organisational factors such as budget and stakeholder buy-in, could impact on implementation and should be addressed to recommend a strategy to overcome such factors. Undertaking an audit provided clear and concise local data 52 . Clinician-led improvement projects are associated with stronger efficacy and larger effect sizes than those that are manager-driven 53 . This highlights the importance of nurses and other health care professionals initiating and being involved in projects similar to this.

This audit was initiated following nurses’ identification of a problem with Claudia to improve care provided to patients like Claudia. The findings from this audit provided data which confirmed evidence that there were substantial issues with equity and access for patients living in this LHD with LLUs. This impacted on VLU outcomes such as the case demonstrated by Claudia. Response from the district has been the supply of portable Doppler for WSNs to perform ABPI and to identify aetiology and commence graduated compression therapy. For Claudia this meant she was able to have a formal assessment of her legs undertaken by the WSNs. She commenced on graduated compression therapy and, as a result, her VLU healed within five months.

Limitations

The audit examined a small number of patients with an LLU. The small sample sizes meant reduced power and effectiveness of statistical tests.

This paper describes a case study, which led to a collaborative of WSNs, an academic and a summer scholar to undertake a study comprising five stages which addressed an identified problem with VLU care in PHC. The findings from this study highlighted gaps in EBP that affected quality care. This was addressed by implementing VLU best practice evidence into PHC in one LHD. The audit offered an opportunity to address practice gaps and allow the LHD to re-align itself with EBP. This process has changed policy to ensure patients living with VLUs have access to appropriate diagnostic services and the best available treatment.

Implications

It is a timely reminder that, despite the availability of clinical guidelines, EBP may not be followed. An audit provided evidence of which elements of care are effective and where there are gaps in practice, identifying where quality improvements can be made. Our study confirmed that an audit provided data and, combined with current EBP, literature can empower clinicians to seek and sustain change.

Acknowledgement

We wish to thank Judith Fethney, statistician at the University of Sydney Susan Wakil School of Nursing and Midwifery for her guidance in the statistical analyses.

Alanda Vincent received a stipend of A$2000 from The University of Sydney Susan Wakil School of Nursing and Midwifery as part of the Summer Scholar Program to develop research skills. No other authors received funding for this study. As a result of the project, Panagiota Avramidis, Naomi James and Rebecca Armstrong were awarded A$10,000 by Sydney Local Health District to purchase equipment. There was no involvement in project execution by either funding source.

Conflict of Interest

There are no conflicts of interest for any of the authors.

Sue Randall* RGN, PhD. Senior Lecturer in Primary Health Care Nursing University of Sydney Susan Wakil School of Nursing and Midwifery Camperdown, NSW, Australia Email [email protected]

Panagiota Avramidis RN, PGCE Wound Clinical Nurse Specialist 2, Sydney District Nursing, Sydney Local Health District NSW, Australia

Naomi James RN, PGCE Wound Clinical Nurse Specialist 2, Sydney District Nursing, Sydney Local Health District NSW, Australia

Alanda Vincent RN Glebe Family Medical Practice, Glebe, NSW, Australia

Rebecca Armstrong RN former Wound Consultant Nurse, Sydney District Nursing, Sydney Local Health District NSW, Australia

Michelle Barakat-Johnson RN, PhD District Lead Nurse Consultant, Pressure Injury Prevention and Management, Sydney Local Health District; Lecturer, Faculty of Medicine and Health University of Sydney, NSW, Australia

* Corresponding author

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  • Experiences of Venous Leg Ulcer persons following an individualised nurse-led education: protocol for a qualitative study using a constructivist grounded theory approach
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  • http://orcid.org/0000-0001-6407-455X Paul Bobbink 1 , 2 ,
  • Philip J Larkin 3 ,
  • http://orcid.org/0000-0001-9603-1570 Sebastian Probst 1
  • 1 HES-SO, University of Applied Sciences and Arts Western Switzerland , Geneva School of Health Sciences , Geneva , Switzerland
  • 2 University Institute of Higher Education and Research in Healthcare , Faculty of Biology and Medicine, University of Lausanne , Lausanne , Switzerland
  • 3 University of Lausanne and University Hospital Lausanne , Lausanne , Switzerland
  • Correspondence to Paul Bobbink; paul.bobbink{at}hesge.ch

Introduction Venous leg ulcers are slow-healing wounds with a high risk of recurrences. To prevent recurrences and promote healing, different nurse-led educational interventions have been developed. The impact of these interventions on self-management is ambiguous. Also, how persons with a venous leg ulcer experiences these educational sessions are poorly described.

Aim This study protocol presents the methodology to provide a comprehensive explanation of participants’ journeys—of how they experience their individualised education sessions concerning self-management.

Methods and analysis A constructivist grounded theory approach according to Charmaz involving 30 participants will be used. Data will be collected through semistructured face-to-face interviews. Interviews will be transcribed verbatim and analysed with initial and focus coding using MAXQDA. Data collection and data analysis will occur iteratively, focusing on constant comparison to obtain well-developed categories. Categories will be reinforced using existent literature.

Ethics and dissemination This pre-results study is embedded in a clinical trial ( NCT04019340 ) and approved by ethical committee of the canton of Geneva (CCER: 2019-01964). A theory will emerge from participants’ journeys informing future education sessions for patients with venous leg ulcers. The findings will be disseminated through peer-reviewed publications and communications.

  • dermatology
  • qualitative research
  • wound management

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ .

https://doi.org/10.1136/bmjopen-2020-042605

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Strengths and limitations of this study

This study protocol demonstrates how a constructivist grounded theory approach highlights patients’ voices.

A systematic and iterative approach with constant comparative analysis will enable the refinement of relevant categories.

The results of the study will be a production of inductively derived generalisations about patients with venous leg ulcer following a standardised education programme.

Theoretical sampling is challenging for a grounded theory study protocol.

Introduction

Venous leg ulcers (VLUs) are defined as a loss of skin on the lower leg or foot taking more than 6 weeks to heal. 1 They are the most frequent aetiology of leg ulcer (70%) and are associated with chronic venous insufficiency. 2 The estimated prevalence of VLUs is approximately 0.9% of the global population, 3 4 is higher in women 4 and rises above 2% in the population aged >85 years. 4–6 Management of VLUs is costly. In the UK, annual costs associated with VLUs are estimated at £941 million. 7 All these numbers will increase over the next years due to the ageing of the population. 8

VLUs are slow-healing wounds as only 53% of VLUs heal within 1 year. 9 Once healed, they are associated with a high recurrence rate estimated at 39% at 6 months and 57% at 1 year. 10 Persons with VLUs experience symptoms including pain, insomnia, exudate and odour. 11 Qualitative data identified pain as the worst symptom and described it as burning, shooting or itching. 12 Moreover, up to 64% of persons with VLUs will experience four or more symptoms at the same time. 13

Persons with VLUs have to cope with other chronic conditions such as hypertension, musculoskeletal disease or atrial fibrillation, which are frequently (90%) associated with VLUs. 14 This complex situation has a big impact on quality of life 15 and provides challenges for individuals when managing their multiple diseases.

The gold standard used to enhance healing and prevent VLU recurrence is compression therapy. 16 Heyer et al 17 stated that only 40.6% of patients with VLU received compression therapy. Non-adherence to therapy is frequently described in this population. 18 19

Reasons for non-adherence are multidimensional, 20 including discomfort and pain associated with compression therapy 21 22 or conflicting advises by healthcare professionals, 23 and frequently lead back to misunderstanding the underlying causes of their VLUs 24 25 or the benefits of self-care activities such as walking or resting in an optimal position. 26 Knowledge deficit is a frequent hypotheses for why chronic venous disease develops into a first VLU 27 or a recurrence. 28 Conversely, adherence to compression therapy improves with participants’ knowledge level. 29

To address knowledge deficit, promote healing and prevent VLU, patient-education has to be multifaceted and oriented towards protective factors intended to prevent recurrence. This includes increasing knowledge about their disease and skills such as why and how to wear compression stockings 16 30 31 and promoting mobility, 32 leg elevation, walking, and ankle and foot exercises, 33 34 as well as the benefits of micronutrients including a vitamin-rich diet. 35 Providing written materials such as brochures for patients with VLU could improve their knowledge. 36 Protz et al 36 suggest that written information must be used in an educational setting in which patients have the opportunity to ask questions. When they arise, nurses mostly respond to these questions as they provide most of the wound care interventions. 7 9 Moreover, nurses have developed multiple individualised patient education programmes. 37–42

However, different systematic reviews 31 43 reveal a lack of high-quality randomised controlled trials (RCTs) that address the effectiveness of these interventions on adherence to therapy or wound healing. For this reason, Probst et al 44 45 developed an interprofessional educational intervention to promote wound healing and self-management strategies. This individualised nurse-led education programme will start with face-to-face meetings between a tissue viability nurse and participants. During the first meeting, the study nurse will provide an evidence-based brochure. This first step of the educational process will provide participants with an opportunity to learn about various aspects of their disease and receive evidence-based recommendations for individualised treatment. To evaluate the effectiveness of this intervention, an RCT design with 124 participants will be used. 45 However, these results will not provide information about the process and the reasons for its effectiveness. 37

Van Hecke et al 37 described cognitive changes associated with understanding what lifestyle adaptations to implement and why, as well as implementing behaviour changes through creative lifestyle and emotional efforts associated with gaining hope and a new perspective. Learning and implementing change is not a simple task for patients. Moreover, the intervention itself, its context, the environment and conditions can affect the learning process. 46 The nurse–patient relationship is important in face-to-face educational sessions. Phillips et al 12 reviewed contradictory data and revealed that good communication was perceived positively. In fact, a good communication and a trusting relationship seem to promote compliance. 47

However, nothing is known about how patients with VLUs experience nurse-led educational programmes and implement lifestyle changes.

Aims and objectives

This study aims to develop a comprehensive contextualised explanation of how patients with VLU experience an individualised patient education programme regarding self-management of VLUs (hereafter their journey).

The study’s objectives are as follows:

Qualitatively map journeys.

Identify self-management strategies and decisions within these journeys.

Identify the contextual and personal perception of behaviour change shaping their journey

Provide a comprehensive explanation of the participants’ experiences/process of individualised educational session.

A grounded theory (GT) is best suited to investigate a process, interactions between individuals or journeys through an illness condition. 48 GTs are used in health and social sciences to generate theoretical accounts of psychosocial processes. 49 However, philosophical perspectives of GTs varied across authors. 50 To provide a congruent method between the principal investigator and the research field, a constructivist grounded theory (CGT) 51 52 was chosen. This inductive approach is widely used in nursing and allows for exploring the process of patient education. It takes into consideration the concerns of participants who are involved in the process and the researcher’s preliminary knowledge and experiences about the clinical field. According to the PhD project, a preliminary literature review and scoping review 53 were conducted to expose the gap of existent knowledge. These preliminary reviews are congruent with a CGT methodology to reveal how this subject has been addressed previously 54 and could be engaged critically and comparatively in the process. 52 CGT offers researchers the ability to provide interpretative aspects and to co-construct the research via the shared experiences of the researcher, participants and readers. 48 55

This study protocol is a PhD project from PB, a novice qualitative researcher, that is embedded within a larger trial (Clinical Trial Number: NCT04019340 ). The research team consists of two senior researchers: one (SP) with expertise in VLUs, patient education and qualitative designs, and another (PJL) with expertise in methodology for qualitative designs.

Study setting

This multicentre study will be conducted in three outpatient wound care clinics in the French-speaking part of Switzerland.

Participants and recruitment

Participants from the RCT intervention group will be eligible for this study when they have followed five individualised education sessions. The following inclusion criteria will be applied: an existing open VLU, an ankle brachial pressure index between 0.8 and 1.3, aged >18 years and proficiency in French language. Participants will be excluded for not providing consent. 45 After participants complete five individualised education sessions, the intervention study nurse will inform them that PB will contact them to organise an interview.

In GT, the use of theoretical sampling enables well-developed, defined and delimited categories to be obtained. 56 However, this method contends that it is not possible to know the precise sample size in advance. 52 Theoretical sampling is ambiguously used or described in published GT. 57 In CGT, the sample size is determined on the basis of credibility, context and inquiry purpose. 51 52 Evidence demonstrates sample sizes ranging from 20 to 35 participants. 55 58 Taking into consideration the study’s aim, the skills of the interviewer and the extant literature, we expect that 30 participants will provide rich data for an initial sample.

Patient and public involvement

This is a study protocol for a CGT method, and therefore no patients or consumer’s groups are yet involved.

Data collection

PB will collect data using semistructured interviews. This approach encourages articulation of experiences and views of the participants. We have developed initial open-ended questions based on our clinical experience, the scope of the intervention and a literature review. These provide the openness necessary to obtain a broader overview of the field of investigation and listen to participants recounting their journey. 52 Box 1 lists some initial questions translated from French. Charmaz 52 describes intensive interviewing as a method suited for the flexibility and adaptability of CGT and the field of inquiry. It permits data collection adjustments directly during interview as well as during the iterative data collection and analysis process. 52 The interviews were initially planned to take place according to participants’ preferences at their home or the outpatient clinic. However, due to the COVID-19 outbreak in our country, data collection began via telephone call or videoconference to preserve participants’ safety and maintain the study period. Ward et al 59 described the use of telephone interviews as congruent with GT with some strengths, as participants reported feeling more relaxed or not feeling judged for their comments. Reported inconveniences included that telephone interviews did not offer the possibility to observe non-verbal behaviours. The interviews are planned for 45–60 min. If participants agree, the interviews will be recorded digitally for verbatim text transcription. Data collection started in April 2020 and is planned for 12 months.

Initial questions translated from French to English

You followed five consultations with a tissue viability nurse. What was your experience of these consultations?

What was your experience of these meetings in terms of care and treatment?

Could you describe what it changed in your day?

Tell me, how do these sessions influence your journey living with venous leg ulcer (VLU)?

What has been most helpful during this process?

After your experiences, what would you recommend to people with VLUs?

Data management

All data will be saved on a secured, password-protected server at the HES-SO University of Applied Sciences and Arts, Geneva. Only the investigators will have access to the data. In addition, data will be deidentified and archived on the Geneva YARETA portal, 60 which meets Findable Accessible Interoperable Reusable (FAIR) requirements. Sociodemographic data will be analysed using IBM SPSS V.25.0 61 for descriptive statistics. After verbatim transcription and anonymisation of the data, participants will be assigned pseudonyms.

Data analysis

MAXQDA 62 will be used to assist qualitative data analysis. According to Charmaz, 52 coding will be performed using two steps: (1) initial coding process using line-by-line coding to label these fragments with codes and (2) focus coding using codes that recur frequently and seem to be most relevant. These codes include data interpretation, and with further analysis indentify relationships between categories and their orientation on theroretical development. 49 52 55 This systematic and iterative approach with constant comparative analysis of data with data or data with categories will permit refinement of relevant categories during the data collection process. To engage in the analytical process, define links between codes 52 and enhance reflexivity on the process, 63 memo writing will be used. This process will be documented in a ‘memo bank’ stored in MAXQDA. 62 Software-assisted analysis will allow for transparent analysis 49 even if it could take the researcher ‘away’ from his data and lead to a ‘mechanical activity’ in place of a cognitive process. 55 To improve the process, data analysis will be supervised by SP and PJL.

Quality criteria and expected outcomes

GT evaluation criteria depend on the approach. 63 Charmaz 52 defined criteria for quality as credibility, resonance, originality and usefulness. Credibility will be assumed based on the scope and depths of the interviews and the quality of the iterative process to obtain links between data and categories. Resonance will, first, be discussed during intensive interviewing with participants to obtain well-developed categories and, second, when sharing the outcomes with persons involved in the patient education process and during literature reviews aiming to extend and challenge theoretical development. 52 Finally, as this is a PhD thesis and the data are collected via person’s experiences, interactions and existent literature, we hope that this project will provide a well-developed theory that includes refined concepts to better understand patient experiences and the development of clinical practices regarding the outcomes.

Ethics and dissemination

The ethics committee of canton of Geneva approved this study (CCER: 2019-01964). All participants will receive an informational document and a consent form detailing the objectives of the study, the procedures involved, insurance and data confidentiality. All participants must provide their written consent prior to data collection.

This is the first study focusing on the process of how participants experience an individualised patient education programme related to self-management. Supervision by senior researchers for method and rigour during the process will allow this project to propose an image of a reality that will be co-created between the research team, participants and actual knowledge. Outcomes will be disseminated via publication papers, oral presentations or posters to provide a new insight and support VLU patient education. Quality of the publications will be ensured using GUidelines for REporting GT research studies (GUREGT). 64

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Contributors PB designed the study and wrote the initial manuscript. SP originated the concept of the project, supervised the design and acquired the funding. PJL provided support for design. PB, PJL and SP contributed to writing or reviewing the manuscript. All authors revised the manuscript and approved the final version to be published.

Funding This work is part of a PhD project funded by the Swiss National Sciences Foundation (SNF; number: 10531C_185332) and supported by the HES-SO University of Applied Sciences and Arts Western Switzerland, Geneva, Switzerland.

Competing interests None declared.

Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

Patient consent for publication Not required.

Provenance and peer review Not commissioned; externally peer reviewed.

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  • Angela Tinkler , BSc(HONS), PG DIP 1 ,
  • Julie Hotchkiss , SRN, MPH, HON MFPHM 1 ,
  • E Andrea Nelson , RGN, BSc(HONS) 2 ,
  • Liz Edwards , RGN, DN, BSc(HONS) 3
  • 1 Wirral Health Authority, St Catherine's Hospital, Merseyside, UK
  • 2 University of York, York, UK (Department of Nursing, University of Liverpool at time of project)
  • 3 Wirral and West Cheshire Community NHS Trust, Merseyside, UK

https://doi.org/10.1136/ebn.2.1.6

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Leg ulceration is a chronic, recurring condition and it is estimated that 1% of adults will have a leg ulcer at some time. The majority of leg ulcers are due to venous disease, with arterial disease, diabetes, auto-immune diseases, and malignancy accounting for about 25%. In the UK, leg ulcers are usually managed by nurses. 1 A systematic review of research on compression bandaging concluded that venous ulcers should be treated with multilayer high compression bandaging. 2 No particular high compression bandaging regimen was found to be superior; Unna's boot, short stretch bandages, and multilayered elastomeric systems were all effective. Simple wound dressings are generally placed underneath the bandage and over the ulcer to allow healing to occur without drying of the wound and to prevent trauma on dressing removal and sensitisation to topical preparations.

In the Wirral, a mixed rural and urban area in north west England (population 332 000), we implemented 2 effective compression bandaging regimens. The use of appropriate primary wound dressings was also implemented as there is no evidence that semiocclusive or occlusive dressings such as foams, films, or hydrocolloids are more effective than simple, inexpensive dressings (eg, knitted viscose dressings or saline gauze) for venous leg ulcers. 3 This paper describes the changes in practice and patient outcomes after the implementation of evidence-based guidelines for assessment, bandaging, and wound dressing.

Baseline audit

An initial audit of leg ulcer care and patient outcomes was commissioned using data collected by local practitioners. The local prevalence of ulceration (1.42 ulcers per 1000 people) was similar to national estimates for the UK. 21 different types of dressings were used. Of 319 ulcers, 83 (26%) were treated with dressings that contained iodine, 60 (19%) with hydrocolloid dressings, and 42 (13%) with knitted viscose dressings. 14 types of cream or ointments and 30 …

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Case Study. This essay will examine the nursing process involved in managing chronic venous leg ulcers (CVLU).

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This essay will examine the nursing process involved in managing chronic venous leg ulcers (CVLU). The decision to focus on CVLU was made during a community placement where their treatment accounted for more than half of nurse’s workload.  According to Posnett et al. (2009), CVLU affect 1-2% of the UK population with over half having an active ulcer for more than one year, costing the National Health Service (NHS) between £266- £314 million. Personal cost to individuals living with CVLU was highlighted by Briggs & Flemming (2007). They report the majority of CVLU sufferers find it incapacitating with physical impacts such as pain & reduced mobility along with psychological impacts of low self-esteem, depression & social isolation. NHS Choices (2012a) define leg ulcers as sores below the knee that are non-healing by six weeks. They advise that different ulcers such as diabetic, traumatic & arterial ulcers can occur however Brown (2011) states around 80% of ulcers are venous. CVLU occur when blood in the lower extremities cannot adequately return to the heart causing hypertension & congestion in the legs. This occurs when calf muscle pump function is reduced, failing to pump blood back towards the heart or if valves in the leg veins that normally prevent blood flowing backwards are damaged. Pressure forces blood and fluid through the capillaries, resulting in irritation to the skin, causing ulceration (Brown, 2011). To illustrate the nursing process, consent was obtained to follow the care of a lady with CVLU, renamed Agnes ensuring confidentiality in line with the Nursing & Midwifery Council (NMC) Code of Conduct (2008).

Agnes, a cognitively bright 68 year old widow has been receiving treatment for CVLU for over 10 years. She became housebound in the last 5 years. Hess (2011) advises healing declines with age due to a number of factors such as poorer hydration, reduced circulation, respiratory or immune function or poor nutritional intake. Living alone, Agnes suffers social restriction and isolation due to reduced mobility. Palfreyman (2008) concurs this is common amongst CVLU patients.  Agnes presented with recurrence of an ulcer on the medial gaiter region of her left leg. She was previously diagnosed with chronic venous insufficiency through assessment of medical history, leg, ulcer, symptoms & ankle brachial pulse index (ABPI) measurement.

Ousey and Cook (2011) specify the importance of specialised training & expertise in wound assessment as it forms the basis of wound care & management and their efficacy. Incorrect diagnosis costs the NHS greatly in wasted resources and extended pain & suffering for CVLU sufferers.  Assessment should not only be about the wound. It should take into account the individual’s co-morbidities, their health beliefs and capacity for healing (Benbow, 2011). The assessor must be knowledgeable in the healing process and factors that affect healing (Hess, 2011).

Full medical history ruled out peripheral arterial disease (PAD), r heumatoid arthritis and diabetes as these conditions affect healing and require specialist referral (Scottish Intercollegiate Guidelines Network, SIGN 2010). It’s good practice to check blood pressure, urinalysis and blood to rule out conditions such as cardiovascular and renal disease, diabetes, anaemia and check nutritional status (SIGN, 2010).

Familial history of leg ulcers was noted. Agnes also suffers o steoarthritis in both knees, a degenerative condition that causes inflammation to joints, cartilage impairment & bone abnormalities around the joints (NHS Choices, 2012b).  Being overweight, with a body mass index of 31, increased burden to her knees causes her pain walking, which has latterly seen her mobility reduced. Hess (2011) claims that obesity can impair wound healing through comprised blood supply due to superfluous adipose tissue or protein malnutrition, suggesting nutritional status is biochemically tested as patient appearance is not reliable. Obesity also increases risks of cardiovascular disease, diabetes, atherosclerosis & hypertension according to Lazarou and Kouter (2010).

Prescribed tramadol & paracetemol, Agnes doesn’t complain about pain. On the surface, she appears stoic however does suffer low spells. Benbow (2011) insists individual’s health beliefs must be considered as barriers to concordance and healing. This is corroborated by Agnes’ non-concordance with compression stockings. Agnes watched her mother suffer and believes nothing will work. She has no issues with continence & has never smoked or drank alcohol. The nurse completed her assessment, based on Roper et al. activities of living model of nursing. Described by Mooney and O’Brien (2006) as assessment of twelve different areas, providing a picture of how individuals manage their daily life and identifying areas that require assistance. With reduced mobility highlighted, a Waterlow assessment was completed. With Agnes at risk of developing a pressure sore, a pressure-relieving cushion was supplied. The assessment identifies incontinence, reduced mobility, and malnutrition as risk factors of developing pressure sores (Healthcare Improvement Scotland, 2009a). With patient assessment complete, the wound was examined.

Hess (2011) suggests ulcer assessment should include site, appearance of wound bed, description of shape & edges, exudate, surrounding skin and pain. According to Whitehurst (2007), underlying causes must be investigated as this dictates a safe & effective choice of treatment. Closs et al. (2008) claims CVLU tend to be shallow, superficial, moist & granulating with irregular borders, found on the lower leg. Agnes ulcer measured six centimetres long by five centimetres wide. It appeared superficial with a red granulating base and moist with low exudate. Benbow (2011) insists standardised data from wound assessment reduces personal interpretations, providing baselines to measure efficacy of treatment and evaluate healing. The general wound assessment tool was used to document & evaluate Agnes’ wound and treatment (HIS, 2009b). T ang et al. (2012) found consistent & on-going wound assessment documentation provides a basis for increased healing.

With no signs of infection, there was no need to swab the ulcer however Agnes was informed of the associated symptoms such as increased pain, exudate or swelling, pain, malodour or temperature. Cooper et al. (2009) advise that most wounds contain some level of bacteria & there is no impact on healing. Unless classic signs of colonisation occur, there is no value in swabbing for infection.

Agnes lower left leg presented with unilateral peripheral oedema and hyperpigmentation, due to hemosiderin deposition, which is common in CVLU. (Hess, 2011). The leg was initially macerated and excoriated which according to Stephen-Haynes (2011) is caused by high exudate levels. This had now improved through application of absorbent dressings initially. Both ankles showed signs of reduced mobility, an indicator of calf muscle pump function which according to Shiman et al.(2009), points to a venous aetiology, compression therapy being the gold standard treatment. O’Meara et al. (2009) found that compression therapy is better than no compression in treatment of CVLU. Keen (2008) advises high compression may be damaging where blood supply is already compromised, so ABPI assessment must be performed before compression is commenced.

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According to Young (2011), ABPI cannot diagnose CVLU however it is a reliable tool for identifying PAD. Due to complex interpretation, it must be undertaken by trained practitioners. The measurement is calculated by measuring the highest pressure recorded in the ankles divided by the highest recorded brachial pressure in the arms. SIGN (2010) recommend compression therapy for measurements >0.8, with readings <0.8 referred to vascular specialists. Agnes ABPI measurement 1.0 demonstrated her safe for compression.

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Compression provides pressure against the venous leg pump, prevents backflow by increasing valve sufficiency & promotes reabsorption of oedema, effectively improving venous return and reducing venous hypertension. Compression must be applied by skilled practitioners. Incorrectly applied, compression can cause skin and leg damage, however more commonly, causes pain & discomfort. It should be used in caution in cardiac or renal disease to avoid cardiac overload Todd (2011).

Bandaging systems and hosiery deliver varying levels of compression and according to Todd (2011) hosiery is most effective in prevention of recurrence. The most common bandaging systems for treating active ulcers are described as short-stretch and multicomponent. Before deciding which compression is suitable, practitioners should consider dimensions of the limb, application frequency, patient’s lifestyle, choice and likely concordance (Anderson & Fernandez, 2008). With short-stretch suitable for more mobile individuals, the multicomponent 4-layer system, most commonly used in the UK was decided suitable for Agnes due to its success in the past. O’Meara et al. (2009) found that multicomponent systems are currently the most effective treatment for CVLU with a simple primary dressing.

Under Agnes’ compression, a non-adherent dressing was used as recommended in SIGN (2010). Hess (2011) suggests a moist wound environment as optimal however wound healing maintains a balance between over-hydration and too dry. Whilst Cutting (2010) recommends routine washing with normal tap water is not required at every change, maintenance debridement of slough & necrotic tissue should be removed if observed to stimulate the wound to promote healing (Tang et al., 2012). This was observed on visits when required as well as moisturising the surrounding skin with emollient to protect skin integrity (Royal College of Nursing, RCN, 2006).

At present, Agnes continues to receive weekly visits where evaluation of the wound is performed and leg redressed with a goal for complete healing within twelve weeks. Focus continues to be around wound healing with the care plan aimed at providing optimal conditions for healing & management of complications (Hess, 2011).  Anderson (2012) suggests changing the focus from wound healing to priorities of care aimed at relieving symptoms the patient finds most debilitating. Interventions to educate & advise health promotion should be considered as this increases patient satisfaction & improves outcomes.

There was no assessment or management of psychological well-being or quality of life indicators as is mentioned by Palfreyman et al. (2010). Briggs and Flemming (2007) concur with Anderson (2012) that the social & psychological impacts are commonly pushed aside by nurses, making physical healing the priority.  They suggest a change is required for both patients and professionals to see this condition as chronic, with the emphasis shifting from traditional nursing care to empowering individuals to self-manage their own long term condition. Better communication, allowing patients to be part of their own care and collaboration with other multidisciplinary teams (MDT) will go a long way in meeting the aims of the Healthcare Quality Strategy for NHS Scotland (Scottish Government, SG,2010) to deliver  safe, effective, patient-centred care to every individual requiring healthcare in Scotland.

The Quality Strategy drives the implementation of the National Action Plan: Improving the Health & Wellbeing of People with Long Term Conditions in Scotland (SG, 2009).  It refers to long term conditions (LTC) as those lasting over a year. With over 2 million individuals living with LTC in Scotland, due to an aging population the amount of people living with LTC will increase by 23% over the next 25 years increasing further demand on NHS resources. Although CVLU can heal and are not mentioned in the list of LTC (SG, 2009), the list is not definitive. The underlying cause is commonly a chronic condition, with palliative interventions based on managing the continuous cycle of skin healing and breakdown over decades.

The LTC Action plan aims to empower & support individuals to self-manage their condition which means a shift in roles where the professional no longer dictates care. Throughout visits with Agnes, no patient education was observed with the nurse suggesting Agnes lacked the capacity to self-manage. Van Hecke (2011) claims that CVLU sufferers in the community receive less than adequate education about their condition. RCN (2006), make patient recommendations such as leg elevation, weight-loss, exercise which have been proven beneficial in the treatment of CVLU.   Practitioners also must consider alternative solutions in cases of non-healing ulcers such as referral to MDT where required. With reduced mobility, such as in osteoarthritis, Brown (2012) implies collaboration with physiotherapists & occupational therapists would be beneficial to suggest safe techniques to enhance physical capacity, to improve calf muscle pump function and ankle movement or elevation of feet to reduce oedema to enable individual’s capacity for self-management.

Self-management, according to Brown (2010) is defined as increased knowledge of one’s condition, coping strategies, concordance & management of symptoms. For the patient, it may involve managing their condition, maintaining normal daily routines & management of psychological impacts. Some of the earliest trials in self-management were done with arthritis sufferers of various ages (Marks et al., 2005). Through various interventions including support for individual self-management achievements, social persuasion, reinterpretation of symptoms, action-planning & feedback, mastery of new skills & problem-solving strategies, they reported a reduction in physical symptoms & increased psychological wellbeing. Nicholson-Banks (2009) discusses The Expert Patient Program which is a self-management course currently running in the UK. With similar interventions to earlier trials including building self-efficacy, similar positive benefits are being reported. Lorig and Holman (2003) describe self-efficacy, the confidence in one’s self to fulfil behaviours to reach desired goals, as the most essential component in behaviour change.

Marks et al. (2005) claim self-efficacy is linked to past experience and predicts future behaviour, suggesting individuals with low self-efficacy less likely to engage in self-management behaviours. As it’s modifiable and impacts wellbeing, motivation & concordance, there is room for interventions to enhance self-management in chronic patients. Before embarking on patient education, professionals require an understanding of health-related behaviour. Using a health education model provides a framework to begin (Marks et al., 2005).

Crumley (2011) describes Rosenstock’s  Health Belief model as a patient perception model. Using this model could challenge some of Agnes’ barriers to self-management, examining individual’s perceptions & severity of their condition. Agnes witnessed her own mothers suffering and believes nothing can help. Although she suffers reduced mobility, she believes it’s not life threatening so doesn’t take it seriously. The model also focuses on the individual’s need to believe a positive behaviour will reach a desired goal and builds self-efficacy. Individual barriers to change tend to be the biggest indicator of success. If Agnes feels the effort is not worth the benefit, success will be limited. To overcome these barriers, identifying what motivates Agnes, as described as internal or external cues to action must be achieved. However motivating the patient is not enough.

Empowered practitioners, suggests Drinkwater (2012) are required for this cultural transformation, claiming insufficient support from qualified staff in promoting the values of self-management. Education programmes to support staff in enabling self-management are needed. Whilst aims to train staff at earlier stages in the hope of it filtering down continue, it’s apparent that this will take time so education for current practitioners is required. Meanwhile, community nurses are best placed to commence support individuals in the community, according to Wrixon (2010) as they are already engaging with people in their own environment. By spending time educating and promoting the benefits of self-management, it may save years in the long run.

Yarwood-Ross and Haigh (2012), suggest that if more patients were provided with the right information they would take a more active role in managing their condition. Ward-Smith (2012) argues that information is not enough, stating that Health Literacy, (HL) must also be addressed. HL is described as the level at which patients have the ability to acquire, process & comprehend health information and services required to make relevant health choices.

In England, 1 in 3 adults over the age of 65 had difficulty comprehending basic health material, according to Bostock and Steptoe (2012). They found low HL is linked to higher mortality rates, with individuals doubling the risk of dying within 5 years, compared to those without HL limitations.  As individuals are living longer and expected to manage their own conditions, better communication tailored to the individual’s needs and information delivered in different formats must be considered to provide individuals with the information & skills required to be true partners in their own care.

This essay examined the nursing care of one lady suffering from CVLU in the community. Following the nursing process from assessment through to evaluation, application of theory to practice was observed in line with national guidelines and clinically, care was delivered safely and was evidence-based. However in light of new Government policy promoting patient engagement and self-management of LTC, the care was not patient-centred, didn’t consider psychological needs and made no attempt of health promotion. If patients are dying earlier through a lack of comprehension of basic health advice, nurses have a duty of care to provide patient education, tailored to individual understanding to enable patients to be shared partners in their own care. Going forward, patient education should be considered every bit as important as choosing the correct dressing.

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Case Study. This essay will examine the nursing process involved in managing chronic venous leg ulcers (CVLU).

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Chronic Wound Management: Leg Ulcers

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  • Int Wound J
  • v.15(3); 2018 Jun

What is the effect of exercise on wound healing in patients with venous leg ulcers? A systematic review

Daisy smith.

1 Monash Nursing and Midwifery, Monash University, Clayton Victoria

Rebecca Lane

2 Department of Physiotherapy, Monash University, Frankston Victoria

Rosemary McGinnes

Jane o'brien.

3 School of Health Sciences, University of Tasmania, Tasmania Australia

Renea Johnston

4 Department of Epidemiology and Preventive Medicine, Monash University, Melbourne Victoria

Lyndal Bugeja

Victoria team, carolina weller.

Standard best practice for the treatment of venous leg ulcers (VLUs) is compression bandaging of the lower leg to reduce hydrostatic pressure. There is considerable variation in reported healing rates when using this gold‐standard approach; therefore, a systematic and robust evaluation of other interventions is required. Exercise interventions, in addition to standard compression therapy, could improve wound‐healing time and prevent their recurrence. We have conducted a systematic review to examine the effects of exercise on wound characteristics, including time to heal, size and recurrence, pain, quality of life, adverse events, and economic outcomes. This review was registered with PROSPERO 2016:CRD42016046407. A systematic search of Ovid Medline, Ovid EMBASE, Ovid CINAHL, The Cochrane Library, PsycINFO, Web of Science, and PEDro was conducted on January 30, 2017, for randomised control trials to examine the effects of exercise on time to heal, size and recurrence, pain, quality of life, adverse events, and economic outcomes. Six studies met the inclusion criteria, but all had design flaws leading to biases, most commonly performance and selective reporting bias. Three studies compared a progressive resistance exercise programme (PREG) plus compression with compression alone for a period of 12 weeks. Low‐quality evidence indicates the following: possibly no difference in the proportion of ulcers healed (risk ratio [RR] 1.14, 95% CI 0.71 to 1.84, I 2 36%; 3 trials, 116 participants); probably no difference in quality of life (mean difference [MD] 3 points better on 100 point scale with exercise, 95% CI −1.89 to 7.89, 1 trial, 59 participants); possible increase in the risk of adverse events with exercise (OR 1.32, 95% CI 0.95 to 1.85, 1 RCT, 40 participants); and no difference in ankle range of motion and calf muscle pump. Evidence was downgraded due to susceptibility to bias and imprecision. Recurrence, pain, and economic outcomes were not measured in these trials, and time to healing was measured but not fully reported in 1 trial. We are uncertain of the effects of other interventions (community‐based exercise and behaviour modification, ten thousand steps, supervised vs unsupervised exercise) due to the availability of low‐ or very low‐quality evidence only from single trials. The review highlights the need for further research, with larger sample sizes, to properly address the significance of the effect of exercise on VLU wound characteristics.

1. INTRODUCTION

1.1. rationale.

Chronic venous insufficiency is 1 of the least researched cardiovascular diseases, which left untreated causes venous leg ulcers (VLU). 1 Venous insufficiency is the most frequent aetiology (75%‐80%) of VLUs, 2 arising from venous valve incompetence and calf muscle pump (CMP) insufficiency. This insufficiency leads to venous stasis and hypertension, which are associated with reduced ankle range of motion. 3 The CMP is an important regulator of venous blood flow and blood pressure in the lower limbs. 3 During exercise, for example, walking, the calf muscles contract and compress the intramuscular and deep veins, raising venous pressure and propelling blood in the deep venous system to flow towards the heart, while the 1‐way valve function prevents reflux, thereby preventing blood from pooling. 4 Over 70% of patients with VLUs have an impaired CMP, and related to this prolonged wound‐healing time.

Different studies estimate the prevalence of VLUs to be 1% to 3% of the population. 2 Prevalence increases with age to 1% to 2% between the ages of 65 and 95 years 5 and approximately to 2% in people aged 80 years and older. 6 Difficult‐to‐heal VLUs are costly ($4500/patient), and after healing, up to 70% of VLUs may recur. 7 The economic and social burden due to VLUs is expected to rise with the population aging, the global spread of smoking, and the growing epidemics of obesity and type 2 diabetes. 8

Standard best practice treatment includes compression of the lower leg by tight bandaging to reduce hydrostatic pressure in the leg. 1 , 9 , 10 There is considerable variation in reported healing rates when using the gold‐standard approach, compression bandaging. Multi‐layered compression bandaging is reported to heal 23% to 69%of patients after 12 weeks of treatment, 11 , 12 , 13 increasing to 87% at 52 weeks. 12 However, up to 15% to 30% of chronic VLUs do not respond to compression treatment 14 and remain unhealed, even after a year of treatment. 15

Patient compliance with the VLU treatment regimens is a well‐documented problem. 16 Compression bandages are recommended as long as there is evidence of venous disease, which often means that the treatment is lifelong. 16 Compliance with treatment regimens is considered to be an important determinant in wound healing and rate of recurrence. 16 Currently, there is little evidence to suggest that health care system options, such as leg clubs and leg ulcer clinics, increase patients' compliance with long‐term compression therapy. 16

Compliance issues with compression therapy, slow response to this treatment regime, and a high recurrence rate of VLUs suggest that alternative adjunct treatments are necessary, for example, lifestyle advice such as physical activity. 17 Physical activity is any bodily movement produced by skeletal muscles that requires energy expenditure, such as working, playing, carrying out household chores, travelling, and engaging in recreational pursuits. 18 Exercise forms a subset of physical activity and involves a structured, planned, repetitive approach, with the aim to improve or maintain 1 or more components of physical fitness. 18 There is an urgent need to systematically and accurately evaluate exercise interventions to determine whether they improve ulcer healing time and prevent their recurrence. An evaluation is especially pertinent as exercise is a low‐cost intervention with the potential to reduce comorbidities and the burden of disease. 19 Exercise, such as regular walking, if incorporated into the treatment plan for VLU patients, may assist in facilitating the CMP, which in turn can improve healing rates.

1.2. Objective

The aim of this study was to conduct a systematic review to examine the effects of exercise in addition to standard compression therapy on VLU characteristics, including time to heal, size and recurrence, pain, quality of life, adverse events, and economic outcomes.

2.1. Protocol and registration

This systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA). 20 The protocol for this review was registered with PROSPERO 2016:CRD42016046407. 21

2.2. Eligibility criteria

2.2.1. inclusion criteria.

Studies that met the following criteria were included in the review:

  • the study design was a randomised controlled trial (RCT) comparing exercise with other interventions, in addition to standard compression therapy, in all participants.
  • people with a VLU.
  • ‐ strength or resistance training and aerobic activity that involved the lower limb.
  • ‐ land‐ and water‐based.
  • ‐ structured and not structured.
  • ‐ supervised and unsupervised (ie, undertaken at home).
  • ‐ primary outcomes: time to complete healing, proportion of VLUs healed, recurrence of VLUs.
  • ‐ secondary outcomes: health‐related quality of life, wound pain, proportion with adverse events, economic outcomes, calf muscle pump (CMP) function, and range of ankle mobility (ROAM).

2.2.2. Exclusion criteria

Studies were excluded where the exercise comprised flexibility, household chores, and activities of daily living.

2.3. Information sources and Search

An electronic search was conducted on Ovid Medline (1946—January 30, 2017), Ovid EMBASE (1974—January 30, 2017), Ovid CINAHL (1982—January 30, 2017), The Cochrane Library (January 30, 2017), PsycINFO (1806—January 30, 2017), Web of Science (1900—January 30, 2017), and PEDro (1929—January 30, 2017). Medical subject heading search terms and text or keywords associated with the concepts of “physical activity” and “venous leg ulcers” were used (Table ​ (Table1 1 ).

Search strategy

Database: Ovid MEDLINE(R) 1946 to present, with daily update

Search strategy:

2.4. Study selection

Search results were collated in a reference database (EndnoteX5, Thomson Reuters, 2010), duplicates were deleted, and initial screening of titles was independently conducted by 2 reviewers (DS and RMG). A priori inclusion and exclusion criteria were applied at this stage. Two reviewers independently applied inclusion and exclusion criteria to the full texts of remaining references to select studies for this review (D.S. and R.L.). Manual searches of reference lists and citation tracking of papers identified as potentially relevant were also conducted. Discordance between reviewers was resolved by discussion, and when necessary, by a third reviewer (J.O.B.).

2.5. Data collection process and data items

A full‐text review of each included study was conducted by 1 reviewer (DS), and the following data items were extracted: study characteristics, population characteristics, and research design. The following outcome data were also extracted: number of events and participants per treatment group for dichotomous outcomes (proportion of VLU healed, recurrence of VLU, proportion with adverse events) and mean, standard deviation, and number of participants per group for continuous outcomes (time to complete healing, health‐related quality of life, wound pain, CMP function and ROAM). A second author (RL) reviewed the data extraction, and disagreements were resolved via consensus.

2.6. Risk of bias in individual studies

Risk of bias for the included articles was assessed using the Cochrane Collaboration's tool for assessing risk of bias 22 using Review Manager (RevMan) software. 23 We assessed the risk of selection, performance, detection, attrition, and selective reporting biases and other biases (baseline imbalance or uneven application of co‐interventions) as low, high, or unclear. Two reviewers independently rated each study against the criteria (D.S. and R.L.). Discordance was resolved by discussion, and when necessary, by a third senior reviewer (C.W. or R.J.).

2.7. Quality of evidence

We used GRADE to assess the overall quality of the evidence (ie, trials) underpinning each outcome (R.J. and C.W.) (GRADE Working Group). 24 GRADE considers 5 factors in the quality: study limitations (risk of bias), consistency of effect, imprecision, indirectness, and publication bias. High‐quality evidence has no or inconsequential study limitations across trials, consistent effect across trials, little imprecision, little indirectness, and no or unlikely publication bias. Evidence is downgraded to moderate if there is limitation in 1 of the 5 factors (eg, bias that may affect the result), low (for 2 factors), or very low (more than 2).

2.8. Summary measures

The included studies' results were plotted as point estimates, that is, RR with corresponding 95% CI for dichotomous outcomes; mean difference (MD); and 95% CI for continuous outcomes using RevMan software. 23 Authors of trials were contacted to obtain relevant information when this was missing in the published article. If no response was received from the authors of trials, the results were presented as reported in the original trial report.

2.9. Synthesis of results

When possible, outcomes were presented using forest plots. For clinically homogeneous studies, with similar participants, comparators, and using the same outcome measure, we pooled outcomes in a meta‐analysis, using the random‐effects model as the default. 23 Heterogeneity across studies was assessed by the I 2 statistic.

3.1. Study selection

The combined searches yielded 1267 records, of which 90 studies were selected for full‐text review. Of 90 studies, 6 met our inclusion criteria and were assessed in the quantitative synthesis (Figure ​ (Figure1); 1 ); 84 studies were excluded for the following reasons: 67 studies were not RCTs; 7 did not include participants with venous leg ulcers; 5 did not include exercise interventions; 4 were not journal articles; and 1 was a duplicate (Appendix).

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Object name is IWJ-15-441-g001.jpg

PRISMA flowchart of search results

3.2. Study characteristics

Studies were published between 2009 and 2017. All studies were RCTs that involved patients with VLUs. Details of each of the included studies are summarised in Table ​ Table2. 2 . Settings were diverse, including outpatient clinics, 25 , 26 university hospitals, 27 and patient homes 28 , 29 , 30 (Table ​ (Table2). 2 ). Primary outcomes differed among the studies, although all studies reported wound characteristics (time to heal, proportion of ulcers healed, and ulcer recurrence). Intervention and control groups are defined in Table ​ Table3, 3 , and the participants' baseline characteristics are outlined in Table ​ Table5. 5 . Economic outcomes were not reported in any of the studies (Table ​ (Table4). 4 ). Other missing outcomes are outlined in Table ​ Table4 4 .

Characteristics of included studies

Author (y)CountryStudy designSettingStudy period (wk)PopulationNo. of participants ( )Intervention typesOutcomesFunding
Heinen (2012) NLRCTOPC12Adults up to 65 y+ with VLU with mixed aetiology of VI and arteriolar or minor arterial insufficiency

184

IG: 92

CG: 92

IG: Lively Legs programme

CG: CAU

Adherence to therapy, ulcer size, comorbidity, proportion healed¥, and ulcer recurrence¥Radbound University
Jull (2009) NZOpen‐label RCTHB12Adults 18 y+ with VLU

40

IG: 21

CG: 19

IG: PREG in addition to compression.

CG: compression only

CMP function¥, ulcer size, time to complete healing¥, and proportion healed¥Health Research Council of NZ
Meagher (2012) IRLRCTUniversity hospital12 (or until fully healed)Patients with VLU

35

IG: 18

CG: 17

IG: Exercise programme in addition to compression

CG: Compression only

Time to complete healing¥, proportion healed¥, pain¥, ulcer size, and durationNo external source of funding
O'Brien (2013) AUSOpen‐label RCTHB12Adults 18 y+ with VLU

13

IG: 6

CG: 7

IG: PREG in addition to compression.

CG: CAU

Ulcer area and size, time to complete healing¥, proportion healed¥, CMP function¥, and ROAM¥Queensland University of Technology
O'Brien (2017) AUSOpen‐label RCTHB12Adults 18 y+ with VLU

63

IG: 31

CG: 32

IG: PREG in addition to compression.

CG: CAU

Ulcer area and size, ROAM¥, adherence to therapy, time to complete healing¥, proportion healed¥, and health‐related quality of life¥Queensland University of Technology
Szewczyk (2010) PLRCTOPC9Patients with VLU

(32)

IG: (16)

CG: (16)

IG: Extensive supervised exercise programme

CG: Unsupervised exercise programme

ROAM¥, pain¥, ulcer swelling, venous claudication, lipodermatosclerosis, number of ulcers, size and duration, ulcer recurrence¥

Abbreviations: —, not specified/not reported; ¥, indicates outcome was reported in this review; AUS, Australia; CAU, care as usual; CG, control group; CMP, calf muscle pump; HB, home based; IG, intervention group; IRL, Ireland; PREG, progressive resistance exercise programme; NL, Netherlands; NZ, New Zealand; ROAM, range of ankle motion; OPC, outpatient clinic; PL, Poland; RCT, randomised control trial; VI, venous insufficiency; VLU, venous leg ulcer.

Description of intervention and comparison groups

Author (y)Number of intervention groupsIntervention groupComparison group
Heinen (2012) 1Nurse‐led self‐management counselling programme (Lively Legs), consisting of 2‐6 sessions on physical activity and adherence to compression therapy. Adherence to physical activity and compression were assessed, barriers and facilitators for behaviour changed discussed using motivation interviewing, and individual tailored goals were set. Lively Legs programme was based on Social Cognitive Theory, the Precaution Adoption Process Model, and motivational interviewing. The first session involved assessing patients' lifestyles, and subsequent sessions involved evaluation of behaviour change and giving feedback.Treatment according to CBO (2005) guidelines for VLU (wound care and compression). No structured assessment/counselling with regards to lifestyle. Treatment performed at outpatient clinic weekly (on average).
Jull (2009) 1

Home‐based, individually tailored 12‐wk progressive resistance exercise programme in addition to compression. 3‐5‐min warm up of walking followed by heel raises.

Heel raises performed with 1 or 2 arms against a wall for support before participant slowly raises onto tip‐toes. Dosage was 3 sets of reputations at 80% of the participants' maximum (assessed by a registered nurse every 3 wk during the intervention phase). Regimen undertaken on alternate days.

Compression only, visited on same schedule as intervention. All participants received normal district nursing care.
Meagher (2012) 1Home‐based, 12‐wk (or until fully healed) exercise programme whereby participants were asked to perform a target of 10 000 steps per day.Compression only, asked not to alter walking behaviour and received patient information leaflet regarding study aims and objectives. No specific advice regarding exercise was given.
O'Brien (2013) 1

Home‐based, individually tailored 12‐wk unsupervised progressive resistance exercise programme in addition to compression.

The exercise protocol is split into 3 stages

The participants progress through each stage by the various 4 levels

Participants moved on to the next stage once they comfortably completed the current stage for at least 3 days/until ready to progress based on their feedback and in consultation with the principal researcher.

Participants were also encouraged to walk at least 3 times per week for 30 min if possible.

Compression bandaging and wound care. Controls received a brochure about the importance of exercise for adults with VLUs and a pedometer to observe the amount of daily steps.
O'Brien (2017) 1See O'Brien 2013 See O'Brien 2013
Szewczyk (2010) 2

9‐wk exercise programme. All participants walked 3 km daily and completed 3 sets of 15 repetitions of circular foot movements, heel raises, and alternate performance of foot dorsiflexion and plantar flexion each day. All participants performed exercises after applying multi‐layer compression.

Intervention group additionally exercised on training bikes under nurse supervision during outpatient clinic appointment, twice a week for 20 min each time at a moderate pace.

All participants walked 3 km daily and completed 3 sets of 15 repetitions of circular foot movements, heel raises, and alternate performance of foot dorsiflexion and plantar flexion each day. All participants performed exercises after applying multi‐layer compression.

VLU, venous leg ulcer.

Summary of study results

Author (y)Time to healing (wk 12)Proportion healedRecurrenceQuality of lifePainAdverse eventsEconomic outcomesCalf muscle pump functionRange of ankle mobility
Heinen (2012)

IG: (51/92) 55%

CG: (41/92) 45%

by 18 mo.

IG: (32/69) 46%

CG: (38/67) 56%

at 18 mo

HR 0.61, 95% CI: 0.35‐1.06, = .07.

Jull (2009)

IG: (8/21) 38%

CG: (10/19) 53%

Unadjusted HR 0.68, 95% CI: 0.28‐1.68, = .49.

IG: (8/21) 38%

CG: (10/19) 53%

by wk 12.

IG: 59%

CG: 41%

OR 1.32,95% CI: 0.95‐1.85.

VV MD 3.7, 95% CI: −29.9‐22.5, = .8

EV MD 21.8, 95% CI: −3.3 to 46.8, = 0.09

EF MD 18.5, 95% CI: 0.03‐36.6, < .05

VFI MD −0.1, 95% CI: −2.2 to 2.1, = .9

RV MD 6.1, 95% CI: −13.2‐25.4, = .5

RVF MD −10.4, 95% CI: −29.2‐8.4, = 0·3.

Meagher (2012)

IG: (15/18) 83%

CG: (13/17) 76%

= .13

Number of steps was associated with time to healing at wk 1 and wk 4 ( = .052, = .008, respectively).

IG: (15/18) 83%

CG: (13/17) 76%

by wk 12

= .13.

Pain not associated with increasing the number of daily steps ( = 0.45).

Relationship b/w pain and healing time not statistically significant ( = .88).

O'Brien (2013)

IG: (3/6) 50%

CG: (3/7) 40%

by wk 12

χ = 0.11, = .74.

No adverse effects in either groups.

EF = 6.7, = .05

RVF = 7.02, = .04

VFI = 0.29, = .61.

IG: 31.8 ± 6

CG: 23.5 ± 8

O'Brien (2017)

IG: (24/31) 77%

CG: (17/32) 53%

by wk 12

χ (1, = 59) = 2.75, = .09.

IG: 46 ± 10.2

CG:43 ± 8.9

RR 3.00, 95% CI: −1.89‐7.89, = .2.

IG: 32 ± 10.75

CG: 24 ± 10.25

Szewczyk (2010) No association b/w pain and range of ankle mobility.Statistically significant increase in the total range occurred later CG compared with IG.

Abbreviations: —, not specified/not reported; b/w, between; CG, control group; CI, confidence interval; EJ, ejection fraction (%); EV, ejection volume (mL); HR, hazard ratio; IG, intervention group; RR, risk ratio; RV, residual volume (mL); RVF, residual volume fraction (%); VFI, venous filling index (mL/s); VV, venous volume (mL).

Baseline Patient Characteristics

Author, yAge in years (mean)Gender (%)BMIUlcer area (mean cm )Ulcer durationABPI (mean)Mobility (%)
Heinen (2012)

IG: 65

CG: 67

B: 60 F

IG: 31

CG: 29

IG: 9

CG: 8.4

Mean months at baseline:

IG: 7

CG: 7.3

Jull (2009)

IG: 54.6

CG: 53.3

IG: 23.8 M

CG: 72.7 M

Median:

IG: 3.4

CG: 3.1

Median wk:

IG: 23

CG: 28

B: 1.1

W/O aids:

IG: (85.7)

CG: (84.2)

Meagher (2012)

IG: 66

CG: 78

IG: 33 M

CG: 24 M

>25 kg/m

IG: 78%

CG: 59%

<10 cm

IG: 94%

CG: 65%

>10 cm

IG: 5.6%

CG: 35%

Median wk:

IG: 8.5

CG: 15

IG: 1.17

CG:1.00

Independently mobile:

IG: (94)

CG: (82)

O'Brien (2013)

IG: 66

CG: 63.6

IG: 50 M

CG: 42.8 M

IG: 31.7

CG: 36.7

IG: 5.1

CG: 3.2

Mean wk:

IG: 19.5

CG: 34.8

B: 0.07

With aids:

B: 2

O'Brien (2017)

IG: 71.3

CG: 71.7

51.6

IG: 8.8

CG: 6.0

Median wk

IG: 16

CG: 14

Szewczyk (2010)

IG: 76

CG: 71

IG: 75 M

CG: 56.3 M

IG: 43.1 ± 52.6

CG: 47.7 ± 73.2

IG: 7·2 ± 9.55 y

CG: 8.5 ± 9.91 y

Total range of ankle‐leg mobility:

IG: 22.7 ± 12.3

CG: 24.6 ± 12·7

Abbreviations: —, not specified/not reported; ABPI, ankle brachial pressure index; B, both; BMI, body mass index; CG, control group; F, female; IG, intervention group; M, male.

Frequencies and percentages within groups not reported.

3.3. Risk of bias within studies

Three studies described adequate methods of allocation sequence and concealment and were at low risk of selection bias 28 , 29 , 30 (Figure ​ (Figure2). 2 ). The remainder ( n = 3) reported these methods unclearly 25 , 26 , 27 and were at risk of selection bias. All studies were at risk of performance bias, with none of the studies reporting adequate participant blinding. Studies were at low risk of detection bias for physician‐ or investigator‐reported outcomes (time to complete healing, proportion of VLUs healed, recurrence of VLU, range of motion and CMP function) as we judged that knowledge of the intervention would likely have little effect on measurement of these objective outcomes. Studies that included self‐reported outcomes (pain, quality of life, and adverse events) were at risk of detection bias in the measurement of these outcomes. 27 , 28 , 30 Attrition bias was unlikely in the majority of the studies due to few participant losses to follow up ( n = 5), 25 , 26 , 28 , 29 , 30 and 1 study did not clearly report their losses to follow up. 27 We judged 4 studies at low risk of selective reporting bias 26 , 28 , 29 , 30 as they reported primary outcomes fully. However, 2 studies selectively reported outcomes; they measured risk in 1 study ( n = 1) 27 and high risk in 1 study ( n = 1). 25

An external file that holds a picture, illustration, etc.
Object name is IWJ-15-441-g002.jpg

Risk of bias table for included studies

3.4. Results of studies

3.4.1. effects of interventions.

Three studies compared a PREG with compression alone. 28 , 29 , 30 Single studies reported the following comparisons: community‐based exercise and behaviour modification (Lively Legs) vs compression 25 ; Ten Thousand Steps exercise programme vs compression 27 ; and supervised exercise programme plus compression compared with unsupervised exercise plus compression. 26

3.4.2. PREG compared with compression care

Three studies compared a PREG intervention with compression (CC) for a period of 12 weeks ( n = 116). 28 , 29 , 30 Wound recurrence, pain, and economic outcomes were not measured in these trials, and the difference between the groups related to time to complete healing only was reported in a single trial without means and measures of variance per treatment group. Quality of evidence for all other outcomes was downgraded to low quality or very low quality due to risk of biases in studies and imprecision due to low event rates and low number of participants.

3.4.3. Time to complete healing

Time to complete healing was only reported inadequately in 1 study ( n = 40) 28 (Table ​ (Table4). 4 ). Means and standard deviations could not be extracted from the data, nor were they provided upon request; thus, we could not verify the result. Quality of evidence for this outcome was therefore judged as very low due to failure of studies to report the outcome or to report the outcome selectively, presence of performance, and detection biases and imprecision.

3.4.4. Proportion healed

Proportion of VLUs healed was reported at up to 12 weeks for all 3 studies ( n = 116) (see Table ​ Table5). 5 ). Proportions of people with healed VLUs were similar in the compression only group (30/58) and the compression plus exercise (35/58), and there was no statistical difference between groups (RR: 1.14, 95% CI 0.71‐1.84, I 2 36%). Evidence for this outcome was of low quality due to design flaws that rendered the studies susceptible to performance bias and imprecision due to the low number of events and participants.

3.4.5. Quality of life

Low‐quality evidence for quality of life was available from 1 study 30 ( n = 59) using the Medical Outcome Survey Short Form‐8 questionnaire (SF‐8). Physical‐ and mental health‐related quality‐of‐life scores (PCS) did not differ between PREG and CC (MD 3.00, 95% CI −1.89‐7·89, P = .23) (Table ​ (Table4 4 ).

3.4.6. Adverse events

Low‐quality evidence from 1 study ( n = 40) indicates a possible higher proportion of adverse events in the PREG compared with controls 28 (OR 1.32, 95% CI 0.95‐1.85) (Table ​ (Table4). 4 ). Evidence was downgraded due to the risk of bias and imprecision.

3.4.7. CMP function

Two papers reported CMP function ( n = 47). 28 , 29 Air plethysmography (APG) was used to measure venous volume (VV), ejection fraction (EF), venous filling index (VFI), and residual volume fraction (RVF) in both studies. There was no difference between groups for VV scores (MD: 4.13, 95% CI −20.97‐29·24, I 2 0%, P = .75), EF scores (MD: 13.74, 95% CI −3.34 to 30.82, I 2 27%, P = .11), VFI scores (MD: −0.21, 95% CI −1.36‐0.93, I 2 0%, P = .72), or RVF scores (MD: −6.37, 95% CI −19.33‐6.60, I 2 0%, P = .34). Evidence was downgraded to low quality due to the risk of bias and imprecision.

3.4.8. Range of ankle mobility

Two papers reported ROAM ( n = 76), 29 , 30 finding a difference between groups for ROAM in favour of the intervention group (MD: 8.08, 95% CI 3.63‐12.54, I 2 0%,). Evidence was downgraded to low quality due to risk of bias and imprecision.

3.5. Lively Legs exercise programme plus care as usual compared with CC only

One trial of 184 participants compared community‐based exercise and behaviour modification (Lively Legs) plus usual care (wound care, compression bandages at an outpatient clinic) with usual care alone for a period of 18 months. 25 Only 2 outcomes of interest were reported (proportion of ulcers healed and recurrence of ulcers), and only low‐quality evidence underpinned these outcomes due to imprecision and risk of bias. Time to healing, quality of life, pain, adverse events, economic outcomes, CMP, and ankle range of motion were not reported.

3.5.1. Proportion healed

There is uncertainty regarding the differences of proportions of people healed between groups (RR 1.24, 95% CI 0.93‐1.67) due to possible imprecision of the results and risk of selection bias. See Table ​ Table4 4 for the proportions of people healed with regards to the Lively Legs exercise programme plus care as usual and CC only.

3.5.2. Recurrence

There is uncertainty regarding the differences of the number of participants who experienced a recurrent ulcer between treatment groups (RR 0.82, 95% CI 0.59‐1.14) due to possible imprecision around the results and risk of selection bias. See Table ​ Table4 4 for recurrence rates between the Lively Legs exercise programme plus care as usual and CC only.

3.6. Ten Thousand Steps exercise programme plus care as usual compared with CC only

One trial with 35 participants compared a Ten Thousand Steps exercise programme plus care as usual (compression bandages) with CC alone 27 and reported only 1 outcome of interest (proportion healed) at various time points. Evidence was low quality for these outcomes due to risk of biases and imprecision due to the small number of participants. Ulcer recurrence, quality of life, adverse events, economic outcomes, CMP, and ankle range of motion were not measured, and time to healing was measured, but mean data were not reported.

3.6.1. Time to complete healing

Means and standard deviations could not be extracted from the data, and at the time of publication, the authors did not respond to our request to provide the data (Table ​ (Table4 4 ).

3.6.2. Proportion healed

Proportion of ulcers healed is reported at up to 12 weeks and is included in Table ​ Table4. 4 . There was no difference between groups for proportion of ulcers healed (RR: 1.09, 95% CI 0.78‐1.52).

3.6.3. Pain

The visual analogue scale ranging between 0 and 10, whereby a score of 0 indicates no pain and a score of 10 indicates severe pain, was used to assess the participants' pain levels. Means and measures of variance were not reported nor provided upon request; thus, we could not analyse this outcome (Table ​ (Table4 4 ).

3.7. Supervised exercise programme plus compression compared with unsupervised exercise programme plus compression

One trial with 32 participants compared an extensive programme of physical exercises plus compression and a basic programme of physical exercises plus compression for a period of 9 weeks 26 and reported only pain and ankle range of motion at 9 weeks. Time to healing, proportion with healed ulcers, ulcer recurrence, quality of life, adverse events, economic outcomes, CMP, and ankle range of motion were not reported. Due to limited reporting of outcomes, risk of bias and small sample size, the evidence was downgraded to very low quality.

3.7.1. Pain

Pain scores ranging between 0 and 2, whereby a score of 0 indicated no pain, a score of 1 indicated moderate pain, and a sore of 2 indicated severe pain requiring pain killers, was used to assess participant pain levels. Number of events and frequencies were not reported and not provided upon request (Table ​ (Table4); 4 ); thus, we were unable to substantiate the results.

3.7.2. Range of ankle mobility

Means and standard deviations could not be extracted from the data nor were provided upon request (Table ​ (Table4); 4 ); thus, we could not substantiate the results.

3.8. Protocol deviations

The databases searched differed from what was specified in our protocol. The search result initiated by researchers was checked and finalised by a librarian with substantial experience in database searching. On the suggestion of a librarian, we decided to replace the Health Technology Assessment Database with PEDro, a physiotherapy evidence database. We have also amended the date range to optimise the likelihood of identifying all previously published studies, removing the initially imposed restriction to 1990. It was decided to include only RCTs and cluster RCTs to allow for better quality of evidence. Results were presented as per protocol when available, although only outcomes and end of treatment and last follow up were reported. Additional outcomes, such as CMP function and ROAM, were also extracted from the included studies as they were relevant to the assessment of benefits of exercise in VLU populations.

4. DISCUSSION

4.1. summary of evidence.

This systematic review examined 6 RCTs published between 1990 and 2017 that measured the effects of exercise interventions on VLU healing rates, time to healing, recurrence, quality of life, pain, adverse events, and economic outcomes. The key findings are as follows: low‐quality evidence from 3 trials indicates there may be no difference in the proportion of ulcers healed after 12 weeks of a PREG plus compression compared with compression alone. Low‐quality evidence from a single trial indicates there was probably no difference in quality of life and a possible increase in the risk of adverse events. Low‐quality evidence from 2 trials also indicates that there was possibly no difference in ankle range of motion and CMP. Evidence was downgraded due to susceptibility to bias in the trials and imprecision due to the small number of participants. Recurrence, pain, and economic outcomes were not measured in these trials, and time to healing was measured only in a single trial but not fully reported.

Low‐quality evidence from a single trial indicates that a community‐based nurse counselling and behaviour modification and exercise program (Lively Legs) probably did not improve healing rates and VLU recurrence compared with standard care (attendance at an outpatient wound clinic and compression bandaging alone). The evidence was downgraded to low quality due to potential for selection bias and imprecision in the results. Therefore, there is uncertainty about the effect estimates, which further trials are likely to change. This trial did not report time to healing, adverse events, quality of life, pain, or secondary outcomes, such as CMP and ankle range of motion. Low‐quality evidence from a single trial suggests that the Ten Thousand Steps exercise programme does not result in benefits in terms of time to healing, proportion healed, and pain. Very low‐quality evidence from a single trial suggests that a supervised exercise programme plus compression may not confer additional benefits over an unsupervised exercise programme plus compression in terms of ROAM and pain.

The evidence underpinning the results is low quality at best due to bias in the trial design and imprecision. All RCTs included in this review were susceptible to selection, performance, or reporting biases. All of them were small‐scale trials, and even for the few outcomes for which we could pool data, the number of participants or events were small, leading to imprecise effect estimates.

4.2. Strengths and limitations

A noteworthy feature of trials included in this review was the wide variability in study interventions. Many different exercise regimens were prescribed. The diversity in exercise prescription is not surprising given the lack of consensus on the optimal exercise prescription for this patient population. Conversely, the wide variety in study outcomes and measurement methods is surprising. This variation precluded pooling studies and made overall conclusions regarding the relative effectiveness of exercise difficult. The short duration or complete lack of follow‐up data examining the effect of exercise on quality of life and economic outcomes in the long term is also noted. Moreover, data are lacking to support the use of exercise in preventing ulcer recurrence. A further limitation is the non‐specificity with respect to the timing and setting of the exercise intervention. Finally, poor adverse event reporting in most of the studies limits any conclusions about the relative safety of exercise, and the small samples provide insufficient power to detect meaningful differences in rates of rare adverse events.

5. CONCLUSIONS

Chronic VLU healing is a complex clinical problem that requires intervention from skilled, often costly, multidisciplinary wound care teams. There is little evidence from RCTs about which exercise interventions improve healing rates. There are suggestions that exercise interventions may result in the patients more consciously following advice, including performing exercises on regular basis and as a result improving VLU healing rates. This review summarises the best available evidence regarding the effects of exercise on time to complete healing, proportion of VLU healed, recurrence of VLU, health‐related quality of life, wound pain, reported adverse events, and economic outcomes.

There was no statistically or clinically significant change in wound‐healing outcomes. However, this systematic review provides low‐quality evidence that exercise as an intervention improves healing for adults with VLUs or at least trends in a positive direction. It is not known, however, whether the trend towards healing for those in exercise intervention groups occurred as a result of the exercise intervention because there was a lack of studies using direct measures of time to healing. This evidence suggests that positive changes in wound healing may occur despite non‐significant changes in the proportion healed and time to healing. The results show consistent support for the application and feasibility of exercise programmes using self‐management principles and/or nurse‐led counselling programmes. Direct comparisons of RCTs are not possible due to the lack of homogeneity. Future trials should focus on adequate randomisation, concealment of allocation, and blinding of outcome assessors throughout the study.

The evidence suggests that exercise may improve wound healing, quality of life, and physical functioning in adults with VLUs. Although these preliminary results are promising, the findings are based on a relatively small number of trials with significant methodological weaknesses. Furthermore, there is currently no evidence to support the use of exercise regimens to improve wound healing. We emphasise the importance of methodologically rigorous studies, which examine different exercise regimens (eg, moderate vs low‐intensity), which would help to better understand the role of exercise among adults with VLUs and to prevent VLU recurrence. We suggest that the exercise prescription should be reported in detail (frequency, intensity, time and type of exercise) to allow for determination of exercise dose response. To this end, adherence to exercise should be reported for both completion of exercise sessions (attendance) and exercise prescription (intensity and duration). Furthermore, monitoring of activity in the comparison group(s) is necessary to assess potential contamination. Consensus is required on standardised methods of assessing physical fitness and wound healing to allow for pooling of data and for comparisons across studies. Future trials should formally monitor for and report the incidence of the adverse events, such as bleeding or additional wound opening.

Reason for exclusionStudy author, y
Study design was not a randomised control trial

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Azoubel, 2010

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Berard, 2002

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Brown, 2012

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Stucker, 2011

Szewczyk, 2006

Tew, 2015

vonArnim, 1966

Weiss, 1991

Wissing, 1999

Wissing, 1997

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Participants did not have a venous leg ulcer

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Intervention was not exercise

Agu, 2004

Aquino, 2016

Araujo, 2016

Burnand, 1981

Taradaj, 2012

Article type was not a journal article

Klonizakis, 2014

Klonizakis, 2014

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Smith D, Lane R, McGinnes R, et al. What is the effect of exercise on wound healing in patients with venous leg ulcers? A systematic review . Int Wound J. 2018; 15 :441–453. 10.1111/iwj.12885 [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]

  • DOI: 10.37022/jiaps.v9i2.594
  • Corpus ID: 272114308

Healing with Hirudotherapy: A Case Study on Leech Application in Varicose Ulcers

  • Maruf Khan Mohd , Begum Mehmooda , Anees Arif
  • Published in Journal of Innovations in… 13 August 2024
  • Journal of Innovations in Applied Pharmaceutical Science (JIAPS)

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15 References

Managing the patient with venous ulcers, antibiotics and antiseptics for venous leg ulcers., venous ulcer: epidemiology, physiopathology, diagnosis and treatment, chronic ulcer of the leg: clinical history., vein unveiled: an overview of varicose vein, chronic ulceration of the leg: extent of the problem and provision of care., implication of leech therapy and asbab-e-sitta zarooriyah in the prevention and treatment of varicose veins: a comprehensive review, socioeconomic impact of chronic venous insufficiency and leg ulcers, comprehensive method of managing osteoarthritis in line with complementary and alternative medicine - a review, advancements in understanding and managing deep vein thrombosis: a contemporary perspective, related papers.

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