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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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Jull, A, Wadham, A, Bullen, C, Parag, V, Parsons, JGM, Laking, G, Waters, J, Klonizakis, M and O'Brien, J ORCID: 0000-0002-6504-8422 2021 , '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)' , BMJ Open, vol. 11, no. 2 , pp. 1-10 , doi: 10.1136/bmjopen-2020-043420.

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Abstract

IntroductionCompression is the mainstay of treatmentfor venous leg ulcers (VLUs) and there are few effectiveadjuvant treatments. There is only observational evidencesupporting the use of hypochlorous acid (HOCl) as a topicalwound solution on VLU and some limited randomisedevidence for the effect of a prescribed regimen of exercise.Methods and analysis The Factorial4VLU trial is apragmatic, blinded, factorial randomised controlledtrial, with 380 participants receiving either a prescribedexercise regimen compared with usual care and eitheractive HOCl wound solution or placebo wound solution ateach dressing change for up to 24 weeks. All participantswill receive compression therapy. The primary outcome isthe proportion of participants with healed VLU at 12 weeksafter randomisation as adjudicated by blinded review ofulcer photographs. Secondary outcomes are proportionhealed at 24 weeks, time to healing, estimated changein ulcer area, change in 2-Minute Walk Test, change inhealth-related quality of life, incidence of infection andincidence of all-cause adverse events. If either of theinterventions shows a statistically significant positivedifference on healing outcomes, cost-effectiveness will bemodelled using a health service perspective.Ethics and dissemination The Factorial4VLU trialreceived ethical approval from the Northern B Health andDisability Ethics Committee. We plan to publish the resultswithin 1 year of trial completion and will include the resultson the trial registration page.Trial registration numbers Australia and New ZealandClinical Trials Register (http://www.anzctr.org.au)(ACTRN12620000116921); Universal Trial Number (WHO)(U1111-1236-2997).

Item Type: Article
Authors/Creators:Jull, A and Wadham, A and Bullen, C and Parag, V and Parsons, JGM and Laking, G and Waters, J and Klonizakis, M and O'Brien, J
Keywords: venous leg ulcers, exercise, factorial trial
Journal or Publication Title: BMJ Open
Publisher: B M J Group
ISSN: 2044-6055
DOI / ID Number: 10.1136/bmjopen-2020-043420
Copyright Information:

© Author(s) (or their employer(s)) 2021. Licensed under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) https://creativecommons.org/licenses/by-nc/4.0/

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