A 675-patient trial will test whether adjustable hook-and-loop compression wraps heal venous leg ulcers faster than the current gold standard of two-layer hosiery or four-layer bandages. Venous leg ulcers are open sores on the lower leg that fail to heal because of poor blood flow. Compression therapy is the standard treatment, but not all compression systems have been rigorously tested. Two-layer bandages are widely used despite limited evidence, and adjustable wraps—which may be easier for patients to apply and adjust themselves—have never been compared head-to-head with established treatments in a large trial. This leaves clinicians and patients uncertain which option works best. If the trial shows that wraps heal ulcers faster or are equally effective but more convenient, the NHS could shift toward a treatment that is easier for patients to manage at home, potentially reducing healing times, lowering the risk of infection, and cutting nursing visits. The study will also determine which compression method is most cost-effective, helping the health service allocate resources wisely. Two embedded sub-studies will test ways to improve patient recruitment and retention in future wound-care trials.
View original technical description
Background: Compression is an effective treatment for reducing the time to healing of venous leg ulcers. There are three main full compression treatments: 1. Evidence-based compression (EBC: composed of two-layer hosiery or four layer bandages); 2. Two-layer bandages and 3. Adjustable hook-and-loop-fastened compression (compression wraps). Only EBC has been well evaluated: this is the gold standard full compression treatment. Two-layer bandages, whilst relatively under-evaluated, are widely used to treat venous leg ulcers. Compression wraps are also untested but not widely used in venous leg ulcer care: these wraps may have potential advantages over bandages. Because of the varying effectiveness evidence for different compression bandage systems we propose a three arm trial to address treatment uncertainties around compression wraps in a way that is most relevant to decision makers. Aims and objectives: Our key objectives are: • to compare compression wraps with EBC in terms of the time to healing of venous leg ulcers; • to determine whether two-layer bandages are non-inferior to EBC for time to healing of venous leg ulcers; • to determine which is the most cost-effective, full compression treatment for venous leg ulcers; • to undertake at least two studies within a trial to aid recruitment and retention to the trial. Methods: A multi-centre, three-arm, parallel group, pragmatic randomised controlled trial (with a nested internal pilot). The trial will have equal randomisation. Sample size is based on previous research and shows we need to recruit 675 participants with at least one venous leg ulcer. We will follow people up for a maximum of 12 months. Our primary outcome is time to ulcer healing. A mixed methods approach will be used to explore adherence to compression and underlying issues around this which may explain trial findings. Analysis: An intention to treat analysis will be conducted on time to healing and secondary outcomes including health related quality of life, adverse events, pain and time to recurrence. Healing data will be used to update our published network meta-analysis of full compression for venous leg ulcers. We will extend the trial findings by updating and expanding our current decision analytic model in this area. Using this model we will determine the most cost-effective full compression treatment for venous leg ulcers. Timelines for Delivery: The study is 61 months in duration (including a 6 month nested internal pilot). This includes 6 months for site set-up, 49 months for recruitment and follow-up and a subsequent 6 months for analyses and write-up. Dissemination and impact: The results of the study will be disseminated widely through our extensive existing networks. Continued and active work with these stakeholders as well as relevant quality improvement work, which we have developed successfully from our previous large compression trials, will also ensure dissemination is converted to impact. Patient and public involvement: Our Wounds Research Patient and Public Forum, which has 12 members, has informed the design and content of this study. Members will continue to comment on the design of the trial, its documentation, especially that to be read and completed by prospective participants, and dissemination of study results.
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know