Prescribed exercise regimen versus usual care and hypochlorous acid wound solution versus placebo for treating venous leg ulcers: study protocol for a randomised controlled trial (Factorial4VLU)

Andrew Jull; Angela Wadham; Chris Bullen; Varsha Parag; John G M Parsons; George Laking; Jill Waters; Markos Klonizakis; Jane O'Brien

doi:10.1136/bmjopen-2020-043420

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Prescribed exercise regimen versus usual care and hypochlorous acid wound solution versus placebo for treating venous leg ulcers: study protocol for a randomised controlled trial (Factorial4VLU)

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Prescribed exercise regimen versus usual care and hypochlorous acid wound solution versus placebo for treating venous leg ulcers: study protocol for a randomised controlled trial (Factorial4VLU)

Andrew Jull, Angela Wadham, Chris Bullen, Varsha Parag, John G M Parsons, George Laking, Jill Waters, Markos Klonizakis and Jane O'Brien

BMJ Open, Vol.11(2), pp.1-10

2021

DOI: https://doi.org/10.1136/bmjopen-2020-043420

PMID: 33602710

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Abstract

prescribed exercise regimen

venous leg ulcers

compression therapy

wound solution

Factorial4VLU

hypochlorous acid

Introduction: Compression is the mainstay of treatment for venous leg ulcers (VLUs) and there are few effective adjuvant treatments. There is only observational evidence supporting the use of hypochlorous acid (HOCl) as a topical wound solution on VLU and some limited randomised evidence for the effect of a prescribed regimen of exercise. Methods and analysis: The Factorial4VLU trial is a pragmatic, blinded, factorial randomised controlled trial, with 380 participants receiving either a prescribed exercise regimen compared with usual care and either active HOCl wound solution or placebo wound solution at each dressing change for up to 24 weeks. All participants will receive compression therapy. The primary outcome is the proportion of participants with healed VLU at 12 weeks after randomisation as adjudicated by blinded review of ulcer photographs. Secondary outcomes are proportion healed at 24 weeks, time to healing, estimated change in ulcer area, change in 2-Minute Walk Test, change in health-related quality of life, incidence of infection and incidence of all-cause adverse events. If either of the interventions shows a statistically significant positive difference on healing outcomes, cost-effectiveness will be modelled using a health service perspective. Ethics and dissemination: The Factorial4VLU trial received ethical approval from the Northern B Health and Disability Ethics Committee. We plan to publish the results within 1 year of trial completion and will include the results on the trial registration page. Trial registration numbers: Australia and New Zealand Clinical Trials Register (http://www.anzctr.org.au) (ACTRN12620000116921); Universal Trial Number (WHO) (U1111-1236-2997).

Details

Title: Prescribed exercise regimen versus usual care and hypochlorous acid wound solution versus placebo for treating venous leg ulcers: study protocol for a randomised controlled trial (Factorial4VLU)
Authors: Andrew Jull (Corresponding Author) - University of Auckland
Angela Wadham (Author) - University of Auckland
Chris Bullen (Author) - University of Auckland
Varsha Parag (Author) - University of Auckland
John G M Parsons (Author) - University of Auckland
George Laking (Author) - Auckland District Health Board
Jill Waters (Author) - Hope Foundation for Research on Ageing
Markos Klonizakis (Author) - Sheffield Hallam University
Jane O'Brien (Author) - University of Tasmania
Publication details: BMJ Open, Vol.11(2), pp.1-10
Publisher: BMJ Group
Date published: 2021
DOI: 10.1136/bmjopen-2020-043420
ISSN: 2044-6055
PMID: 33602710
Copyright note: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Grant note: This trial is funded by a project grant (#19/069) from the Health Research Council of New Zealand (www.hrc.govt.nz).
Organisation Unit: School of Health - Nursing
Language: English
Record Identifier: 991212663102621
Output Type: Journal article

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