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Open Access 01-12-2023 | Leg Ulcer | Study protocol

A randomised controlled trial of compression therapies for the treatment of venous leg ulcers (VenUS 6): study protocol for a pragmatic, multicentre, parallel-group, three-arm randomised controlled trial

Authors: C. E. Arundel, C. Welch, P. Saramago, U. Adderley, R. Atkinson, I. Chetter, N. Cullum, T. Davill, J. Griffiths, C. Hewitt, C. Hirst, M. Kletter, J. Mullings, G. Roberts, B. Smart, M. Soares, P. Stather, L. Strachan, N. Stubbs, D. J. Torgerson, J. Watson, S. Zahra, J. Dumville

Published in: Trials | Issue 1/2023

Abstract

Background

Venous leg ulcer(s) are common, recurring, open wounds on the lower leg, resulting from diseased or damaged leg veins impairing blood flow. Wound healing is the primary treatment aim for venous leg ulceration, alongside the management of pain, wound exudate and infection.

Full (high) compression therapy delivering 40 mmHg of pressure at the ankle is the recommended first-line treatment for venous leg ulcers. There are several different forms of compression therapy available including wraps, two-layer hosiery, and two-layer or four-layer bandages.

There is good evidence for the clinical and cost-effectiveness of four-layer bandage and two-layer hosiery but more limited evidence for other treatments (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 venous leg ulcers whilst offering value for money. VenUS 6 will therefore investigate the clinical and cost-effectiveness of evidence-based compression, two-layer bandage and compression wraps for time to healing of venous leg ulcers.

Methods

VenUS 6 is a pragmatic, multi-centre, three-arm, parallel-group, randomised controlled trial. Adult patients with a venous leg ulcer will be randomised to receive (1) compression wraps, (2) two-layer bandage or (3) evidence-based compression (two-layer hosiery or four-layer bandage).

Participants will be followed up for between 4 and 12 months. The primary outcome will be time to healing (full epithelial cover in the absence of a scab) in days since randomisation. Secondary outcomes will include key clinical events (e.g. healing of the reference leg, ulcer recurrence, ulcer/skin deterioration, amputation, admission/discharge, surgery to close/remove incompetent superficial veins, infection or death), treatment changes, adherence and ease of use, ulcer related pain, health-related quality of life and resource use.

Discussion

VenUS 6 will provide robust evidence on the clinical and cost-effectiveness of the different forms of compression therapies for venous leg ulceration.

VenUS 6 opened to recruitment in January 2021 and is currently recruiting across 30 participating centres.

Trial registration

ISRCTN67321719. Prospectively registered on 14 September 2020

Available only for authorised users

An estimand is a precise description of the treatment effect to be estimated with regard to five key attributes: (1) population of interest, (2) treatment strategies being compared, (3) outcome of interest, (4) treatment effect summary measure and (5) handling of intercurrent events [18].

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Title: A randomised controlled trial of compression therapies for the treatment of venous leg ulcers (VenUS 6): study protocol for a pragmatic, multicentre, parallel-group, three-arm randomised controlled trial
Authors: C. E. Arundel
C. Welch
P. Saramago
U. Adderley
R. Atkinson
I. Chetter
N. Cullum
T. Davill
J. Griffiths
C. Hewitt
C. Hirst
M. Kletter
J. Mullings
G. Roberts
B. Smart
M. Soares
P. Stather
L. Strachan
N. Stubbs
D. J. Torgerson
J. Watson
S. Zahra
J. Dumville
Publication date: 01-12-2023
Publisher: BioMed Central
Keywords: Leg Ulcer
Venous Leg Ulcer
Venous Leg Ulcer
Published in: Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-023-07349-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

A randomised controlled trial of compression therapies for the treatment of venous leg ulcers (VenUS 6): study protocol for a pragmatic, multicentre, parallel-group, three-arm randomised controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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