A randomised controlled trial of compression therapies for the treatment of venous leg ulcers (VenUS 6)

Manchester University NHS Foundation Trust0 个研究点目标入组 637 人开始时间: 2020年9月14日最近更新: 2024年7月15日

适应症

试验速览

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37237393/ (added 30/05/2023) 2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37964358/ process evaluation (added 16/11/2023)

•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

发起方