A randomised controlled trial of compression therapies for the treatment of venous leg ulcers (VenUS 6)
Venous leg ulcers
Current interventions as of 09/02/2024: The study has a 45-month recruitment period in total (comprising and initial 32 month planned recruitment period plus 13 month extension) including an initial 6 month internal pilot. Follow-up will be variable with participants followed for minimum of 4 months and a maximum of 12 months. Prior to study involvement the clinical care team will screen clinical caseloads at trial sites will assess participants against the eligibility criteria. Patients who may be eligible to participate in the study will be approached by a member of the research team and provided with a patient information sheet and asked to indicate if they would be interested in participating. Patients will be given sufficient time to consider this information. Once eligibility has been confirmed, patients must take part in the consent process. During the consent process, the person obtaining consent will inform the participant of all aspects of the trial (e.g. trial procedures, risks/benefits) in order to allow the participant to make an informed decision about their participation. No protocol specific procedures are performed until the participant has signed and dated an Ethics Committee approved informed consent form. Once informed consent has been obtained, baseline data will be collected and participants then randomised. At baseline participant contact details, GP contact details, diabetes status, weight, height and general mobility and ankle mobility will be determined. Ulcer history and assessment such as duration and area of the reference ulcer, number of previous ulcer episodes, ankle–brachial pressure index and ankle circumference. A photo of the reference ulcer (where a participant has multiple ulcers the reference ulcer will be defined as that with the largest surface area) will be taken in order to monitor healing. Following collection of baseline data, the research team will contact the UKCRC-accredited University of York Trials Unit (YTU) via
1. ≥1 venous leg ulcer 2. Ankle:brachial pressure index (ABPI) ≥0. 8 (taken within the previous 3 months or where an ABPI is not viable, use of locally-approved alternative assessments to rule out peripheral arterial disease i.e. pulse palpation and doppler ausculation toe pressure assessment or arterial imaging also taken within the last 3 months) 3. Able to tolerate full compression 4. Aged ≥18 years
1. Unwilling to wear full compression 2. Leg ulcers of non-venous aetiology (e.g. arterial or rheumatoid) 3. significant peripheral vascular disease which contraindicates full compression ( requiring an APBI of at least 0.8) 4. Ulcers confined to the foot 5. Lacks capacity or willingness to provide consent to participate in the trial 6. Currently participating in another study evaluating treatments for their venous leg ulcer 7. Known allergy to any trial product 8. Previously recruited for this trial 9. Deemed to be not clinically appropriate to take part in the trial (at clinician discretion) 10. On a waiting list for endovenous ablation and is expected to have surgery within 28 days Added 27/08/2021: 10. Planned treatment to close/remove incompetent superficial veins (e.g. via endovenous ablation, sclerotherapy) within 28 days