10.35279/jowm2022.23.01.03

10.35279/jowm2022.23.01.03SCIENCE, PRACTICE AND EDUCATION DOI: 10.35279/jowm2022.23.01.02 VenUS 6 – A randomised controlled trial of compression therapies for the treatment of venous leg ulcers: Study design and update Sabeen Zahra PhD 1 , Catherine Arundel MSc 1 , Katherine Jones PhD 1 , Tom Davill MSc 1 , Gareth Roberts BSc 1 , Jo Dumville PhD 2 , on behalf of the VenUS 6 trial team 1 York Trials Unit, Department of Health Sciences, Faculty of Science, University of York, YO10 5DD 2 Division of Nursing, Midwifery and Social Work, Jean McFarlane Building, University of Manchester, Oxford Road, Manchester, M13 9PL Correspondence: Catherine.arundel@york.ac.uk · Conflict of interests: None Keywords: Compression therapies, randomised controlled trial, time to healing, venous leg ulcer, wound healing ABSTRACT Background Venous leg ulcers (VLU) are common wounds, mainly in the gaiter region of the leg. Compression therapy is an effective treatment for reducing the time to healing of VLU. The four-layer bandage and two-layer hosiery protocols 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 the 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 VLU. Method This multicentre, pragmatic, three-arm parallel group study aims to recruit 675 eligible participants aged ≥ 18 years with at least one VLU, 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 with weekly assessments until the participant’s reference leg is ulcer-free and no further nursing assessments are required to treat the 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 the reference ulcer. Secondary outcomes include clinical events and participant-reported ulcer related pain, quality of life, treatment adherence and resource use. INTRODUCTION Venous leg ulcers (VLU) are common, recurring open wounds on the lower leg resulting from venous insufficiency. Wound care is mainly delivered in community-based clinics, patient homes or outpatient settings. Delivering effective treatments remains important to maximise ulcer-free days and improve the health-related quality of life of people with VLU. Evidence suggests full (high) compression treatment, aiming to deliver around 40mmHg compression at the ankle, is effective for reducing ulcer healing time and is cost effective. 1 More recently, the Early Venous Reflux Ablation (EVRA) trial has reported the early provision of endovenous ablation surgery to further reduce time to healing and JOURNAL OF WOUND MANAGEMENT OFFICIAL JOURNAL OF THE EUROPEAN WOUND MANAGEMENT ASSOCIATION  13Page 2

iPaper

VenUS 6 – A randomised controlled trial of compression therapies for the treatment of venous leg ulcers: Study design and update
Zahra S, Arundel C, Jones K, Davill T, Roberts G, Dumville J

This article should be referrenced as: Zahra S, Arundel C, Jones K, Davill T, Roberts G, Dumville. VenUS 6 – A randomised controlled trial of compression therapies for the treatment of venous leg ulcers: Study design and update. J Wound Management, 2022,23(1):13-17

ABSTRACT
Background: Venous leg ulcers (VLU) are common wounds, mainly in the gaiter region of the leg. Compression therapy is an effective treatment for reducing the time to healing of VLU. The four-layer bandage and two-layer hosiery protocols 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 the 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 VLU.
Method: This multicentre, pragmatic, three-arm parallel group study aims to recruit 675 eligible participants aged ≥18 years with at least one VLU, 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 with weekly assessments until the participant’s reference leg is ulcer-free and no further nursing assessments are required to treat the 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 the reference ulcer. Secondary outcomes include clinical events and participant-reported ulcer related pain, quality of life, treatment adherence and resource use.