VenUS 6 – A randomised controlled trial of compression therapies for the treatment ofvenous leg ulcers: Study Design and Update

Background: Venous leg ulcers (VLU) are common wounds mainly in gaiter region of the leg. Compression therapy is an effective treatment for reducing the time to healing of venous leg ulcers. The four-layer bandage and two-layer hosiery are supported by good evidence for clinical and cost effectiveness. There is more limited evidence for other treatments such as the two-layer bandage and compression wraps. Robust evidence is required to compare clinical and cost effectiveness of these and to investigate which is the best compression treatment for reducing time to healing of VLU whilst offering value for money. Aim: VenUS 6 aims to investigate the clinical and cost effectiveness of evidence-based compression, two-layer bandage and compression wraps for time to healing of venous leg ulcers. Method: This multicentre, pragmatic, three-arm parallel group study aims to recruit 675 eligible participants aged ≥18 years with at least one venous leg ulcer, and who can tolerate full compression and give written consent. Participants are allocated 1:1:1 to receive evidence-based compression, two-layer bandage or compression wrap. Participants are followed up weekly assessments until participant reference leg is ulcer free and no further nursing assessments are required to treat this leg. Reference ulcer healing is confirmed by a healthcare professional/treating nurse. Participant reported outcomes are collected at baseline and at 1, 3, 6, and 12 months. The primary outcome is time to healing of reference ulcer. Secondary outcomes include clinical events and participant reported ulcer related pain, quality of life, treatment adherence and resource use.