Protocol for a pilot randomised controlled clinical trial to compare the effectiveness of a graduated three layer straight tubular bandaging system when compared to a standard short stretch compression bandaging system in the management of people with venous ulceration: 3VSS2008

<p>Abstract</p> <p>Background</p> <p>The incidence of venous ulceration is rising with the increasing age of the general population. Venous ulceration represents the most prevalent form of difficult to heal wounds and these problematic wounds require a significant amount of health care resources for treatment. Based on current knowledge multi-layer high compression system is described as the gold standard for treating venous ulcers. However, to date, despite our advances in venous ulcer therapy, no convincing low cost compression therapy studies have been conducted and there are no clear differences in the effectiveness of different types of high compression.</p> <p>Methods/Design</p> <p>The trial is designed as a pilot multicentre open label parallel group randomised trial. Male and female participants aged greater than 18 years with a venous ulcer confirmed by clinical assessment will be randomised to either the intervention compression bandage which consists of graduated lengths of 3 layers of elastic tubular compression bandage or to the short stretch inelastic compression bandage (control). The primary objective is to assess the percentage wound reduction from baseline compared to week 12 following randomisation. Randomisation will be allocated via a web based central independent randomisation service (nQuery v7) and stratified by study centre and wound size ≤ 10 cm²or >10 cm². Neither participants nor study staff will be blinded to treatment. Outcome assessments will be undertaken by an assessor who is blinded to the randomisation process.</p> <p>Discussion</p> <p>The aim of this study is to evaluate the efficacy and safety of two compression bandages; graduated three layer straight tubular bandaging (3L) when compared to standard short stretch (SS) compression bandaging in healing venous ulcers in patients with chronic venous ulceration. The trial investigates the differences in clinical outcomes of two currently accepted ways of treating people with venous ulcers. This study will help answer the question whether the 3L compression system or the SS compression system is associated with better outcomes.</p> <p>Trial Registration</p> <p>ACTRN12608000599370</p

A qualitative study to explore the attitude of clinical staff to the challenges of caring for obese patients

Aim: To examine, from the perspective of staff, if obese patients have any additional care needs, and what the impact of these care requirements are on care provision. We have selected obese patients with venous leg ulceration as an example patient population to explore these questions. Background: Anecdotal evidence indicates obesity can increase care requirements and have implications for obesity for care provision. However, little research exists nationally or internationally that provides evidence from a health care perspective. Obesity is a contributory causative factor of lower limb ulceration. In addition to affecting the development of venous leg ulceration (VLU), obesity may also impact on the care an obese patient may require and receive. Design: Qualitative study using semi-structured in interviews and framework analysis. Methods: Interviews were conducted with 18 HCPs, and one focus group with 12 HCP who cared for patients with venous ulceration. Data were analysed to identify recurring themes relating to the impact of obesity on care provision. Results: This study found that the increasing numbers of obese patients with leg ulcers are currently presenting challenges to care delivery in many different ways. There was an impact of obesity on patient experience in terms of dignity, safety and quality. Data indicated that neither hospital nor community care services were adequately set up to meet the needs of obese patients in general. Conclusion: Healthcare providers need to recognise that increasing numbers of overweight and obese patients are presenting challenges to care delivery. The study also indicated the need for senior strategic leadership in planning for meeting the needs of obese patients

A 'test and treat' strategy for elevated wound protease activity for healing in venous leg ulcers (Protocol)

This is the protocol for a review and there is no abstract. The objectives are as follows: To determine the effects on wound healing of a 'test and treat' strategy for diagnosing and treating high levels of wound protease activity in people with venous leg ulcers

Systematic review assessing the measurement properties of patient-reported outcomes for venous leg ulcers

Background: A variety of instruments have been used to assess outcomes for patients with venous leg ulcers. This study sought to identify, evaluate and recommend the most appropriate patient reported outcomes (PROMs) for English-speaking patients with venous leg ulcers (VLUs). Method: This systematic review used a two-staged approach. Electronic searches of major databases including MEDLINE were completed in October 2015 and then updated in July 2016. Additional studies were identified from citation checking. Study selection, data extraction and quality assessment were undertaken independently by at least two reviewers. Evaluation and summary of measurement properties of identified PROMs were undertaken using standard and adapted study-relevant criteria. Results: Ten studies with data for three generic PROMS and six condition-specific measures were identified. No generic PROM showed adequate content and criterion validity; however the EQ-5D, Nottingham Health Profile (NHP) and 12-item Health Survey Short-Form had good acceptability with scores ranging from 80% to 91%. In general, the EQ-5D showed poor responsiveness in patients with VLUs. Condition-specific PROMs demonstrated poor criterion and construct validity. Overall, good internal consistency was demonstrated for the Venous Leg Ulcer Quality of Life (VLU-QOL) and the Sheffield Preference-based Venous Ulcer questionnaire (SPVU-5D). Test re-test reliability was also satisfactory for SPVU-5D and VeLUSET measures. Conclusions: The NHP and VLU-QOL seemed the most suitable PROMs for use by clinicians. A valid condition-specific PROM is still required

Community Nurses' Judgement for the Management of Venous Leg Ulceration: A Judgement Analysis

Background: Nurses caring for the large numbers of people with leg ulceration play a key role in promoting quality in health via their diagnostic and treatment clinical judgements. In the UK, audit evidence suggests that the quality of these judgements is often sub optimal. Misdiagnosis and incorrect treatment choices are likely to affect healing rates, patients’ quality of life, patient safety and healthcare costs. Objectives: To explore the diagnostic judgements and treatment choices of UK community nurses managing venous leg ulceration. Design: A judgement analysis based on Brunswik's psychological Lens Model theory. Setting: UK community and primary care nursing services. Participants: 18 community generalist nurses working in district (home) nursing teams and general practitioner services and 18 community tissue viability specialist nurses. Methods: During 2011 and 2012, 36 nurses made diagnostic judgements and treatment choices in response to 110 clinical scenarios. Scenarios were generated from real patient cases and presented online using text and wound photographs. The consensus judgements of a panel of nurses with advanced knowledge of leg ulceration judged the same scenarios and provided a standard against which to compare the participants. Correlations and logistic regression models were constructed to generate various indices of judgement and decision “performance”: accuracy (Ra), consistency (Rs) and information use (G) and uncertainty (Re). Results: Taking uncertainty into account, nurses could theoretically have achieved a diagnostic level of accuracy of 0.63 but the nurses only achieved an accuracy of 0.48. For the treatment judgement (whether applying high compression was warranted) nurses could have achieved an accuracy of 0.88 but achieved only an accuracy of 0.49. This may have been due to the nurses giving insufficient weight to the diagnostic cues of medical history and appearance of the leg and ulcer and insufficient weight to the treatment cues of type of leg ulcer and pain. Conclusion: Clinical judgements and decisions made by nurses managing leg ulceration are complex and uncertain and some of the variability in judgements and choices can be explained by the ways in which nurses process the information and handle the uncertainties, present in clinical encounters

Risk factors for chronic ulceration in patients with varicose veins: A case control study

Background/ObjectiveIdentifying which patients with varicose veins are at risk of progressing to more severe forms of chronic venous disease could help in assigning clinical priorities and targeting appropriate treatments. The aim of this study was to determine, in subjects with varicose veins, the characteristics of venous disease and other factors associated with an increased risk of ulceration.MethodsOne hundred twenty subjects with varicose veins and an open or healed venous leg ulcer were compared with 120 controls with varicose veins and no history of venous ulcer on this case control study. Subjects were recruited from hospital settings and primary care. Each subject completed a questionnaire on lifestyle and medical history and underwent an examination comprising of clinical classification of venous disease (CEAP), duplex scanning, quantitative digital photoplethysmography, and measurement of dorsiflexion. Multiple logistic regression analyses and calculation of receiver operating characteristic (ROC) curves were performed to identify the combination of factors which most accurately predicted which patients with varicose veins will develop leg ulcers.ResultsAn increased risk of ulceration was associated with the severity of clinical venous disease, especially with the presence of skin changes (P < .0001). Other significant risk factors included history of deep vein thrombosis (DVT) (P = .001), higher body mass index (BMI) (P = .006), smoking (P = .009), and reflux in the deep veins (P = .0001). Ulceration was associated with reduced volume of blood displaced as reflected by photoplethysmography and a limited range of ankle movement (not wholly due to the effects of an active ulcer) (both P < .05). Multivariate analyses showed that skin changes including lipodermatosclerosis (odds ratio [OR] 8.90, 95% confidence interval [CI] 1.44-54.8), corona phlebectatica (OR 4.52, 95% CI 1.81-11.3) and eczema (OR 2.87, 95% CI 1.12-7.07), higher BMI (OR 1.08, 95% CI 1.01-1.15), and popliteal vein reflux (OR 2.82, 95% CI 1.03-7.75) remained independently associated with increased risk of ulceration while good dorsiflexion of the ankle (OR 0.88, 95% CI 0.81-0.97) and an effective calf muscle pump (OR 0.96, 95% CI 0.92-0.99) remained protective factors. ROC curve analyses indicated that a model based on clinical observation of skin changes, duplex scanning for popliteal reflux, and calf muscle pump tests would be the most accurate in determining which patients with varicose veins develop leg ulcers.ConclusionsThe results of this study confirm that, in patients with varicose veins, those with skin changes of chronic venous insufficiency and deep vein incompetence are at greatly increased risk of ulceration. However, the risks may also be increased in those who smoke, are obese, and have restricted ankle movement and reduced calf muscle pump power

Effectiveness of acupuncture, special dressings and simple, low-adherence dressings for healing venous leg ulcers in primary healthcare: study protocol for a cluster-randomized open-labeled trial

<p>Abstract</p> <p>Background</p> <p>Venous leg ulcers constitute a chronic recurring complaint that affects 1.0–1.3% of the adult population at some time in life, and which corresponds to approximately 75% of all chronic ulcers of the leg. Multilayer compression bandaging is, at present, the only treatment that has been proved to be effective in treating this type of ulcer. There is no consensus, however, about the dressings that may be applied, beneath the compression, to promote the healing of this type of ulcer, as there does not seem to be any added benefit from using special dressings rather than simple, low-adherence ones. As well as analgesia, acupuncture provokes peripheral vasodilation, in skin and muscles – which has been demonstrated both experimentally and in clinical practice – probably due to the axon reflex, among other mechanisms. The aim of the present study is to measure the effectiveness and cost of compression treatment for venous leg ulcers combined with special dressings, in comparison with low-adherence ones and acupuncture.</p> <p>Methods/design</p> <p>Cluster-randomized open-labeled trial, at 15 primary healthcare clinics in the Sevilla-Sur Healthcare District, with a control group treated with compression bandaging and low-adherence dressings; the experiment will consist, on the one hand, of the compression treatment applied in combination with special dressings (Treatment 1), and on the other, the compression treatment applied in association with low-adherence dressings, together with acupuncture (Treatment 2).</p> <p>Discussion</p> <p>The results will be measured and recorded in terms of the median time elapsed until complete healing of the ulcer, and the rate of complete healing at 3 months after beginning the treatment. An economic analysis will also be made.</p> <p>This study, carried out in the context of real clinical practice, will provide information for decision-taking concerning the effectiveness of special dressings. Moreover, for the first time a high-quality study will evaluate the effectiveness of acupuncture in the process of healing venous leg ulcers.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN26438275.</p