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Abstract
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).
- wound management
- primary care
- clinical trials
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Contributors AJ is the principal investigator, led all stages of the design development, grant application and protocol development. AJ drafted the manuscript. AW, CB, VP, JGMP, GL, JW, MK and JO’B all contributed to the study design, grant application and protocol development. All authors edited the draft manuscript and approved the manuscript for submission. AJ, AW, CB, VP, GL, and JW are members of the TSC. MK and JO’B are international advisors to the project.
Funding This trial is funded by a project grant (#19/069) from the Health Research Council of New Zealand (www.hrc.govt.nz). The hypochlorous acid is supplied by Te Arai BioFarma.
Disclaimer Neither the Health Research Council nor Te Arai BioFarma has any role in the conduct and analysis of the trial, nor will they have any role in the interpretation or decision to publish the findings from the trial.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Author note AJ is a registered nurse and professor at the School of Nursing as well as a senior research fellow at the National Institute for Health Innovation, both at the University of Auckland. AW is a senior project manager at the National Institute for Health Innovation at the University of Auckland. CB is a public health physician and director of the National Institute for Health Innovation at the University of Auckland. VP is a senior biostatistician at the National Institute for Health Innovation at the University of Auckland. JGMP is a registered physiotherapist and associate professor in the School of Nursing at the University of Auckland. GL is a medical oncologist, leader in Māori Health and qualified in health economics. JW is a geriatrician and executive officer of the HOPE Foundation for Research on Aging. MK is a reader in clinical physiology at Sheffield Hallam University. JO'B is an exercise scientist and registered nurse lecturing in nursing at the University of Tasmania.