Introduction Keratins, filament-forming proteins found in vertebrate epithelium, are downregulated in slow-healing venous leg ulcers (VLU) compared with normal-healing VLU. Laboratory and animal model research has suggested exogenous keratins increase expression of endogenous keratins. A non-randomised controlled trial of an exogenous keratin dressing reported increased healing in slow-healing VLU. To date, no randomised controlled trial has been done to verify these promising findings.
Methods and analysis The Keratin4VLU trial is a single-blind, pragmatic, parallel group, randomised controlled trial of keratin dressings compared with usual care non-medicated dressings in patients with VLU where either (1) the ulcer area is greater than 5 cm2, (2) the ulcer has been present for more than 26 weeks or (3) both. All patients will receive compression therapy. The primary outcome is the proportion of patients with healed VLU at 24 weeks after randomisation as adjudicated by blinded review of an ulcer photograph. Secondary outcomes are time to healing, estimated change in ulcer area, change in health-related quality of life, agreement between blinded and unblinded assessors and adverse events. The analysis will be intention-to-treat on the primary and secondary outcomes (excepting health-related quality of life).
Ethics and dissemination The Keratin4VLU trial received ethical approval from the Northern A 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 number NCT02896725; Pre-results.
- venous leg ulcer
- skin substitutes
- bandages and dressings
- wound healing
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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 and JW all contributed to the study design, grant application and protocol development. All authors edited the draft manuscript and approved the manuscript for submission.
Funding This trial is funded by a project grant (16/135) from the Health Research Council of New Zealand (www.hrc.govt.nz). The keratin dressing is supplied by Keraplast Technologies.
Disclaimer Neither the Health Research Council nor Keraplast Technologies have 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 consent Obtained.
Ethics approval Ethical approval for the trial was obtained on 21 September 2016 from the Northern A Health and Disability Ethics Committee (Reference 16/NTA/142) by the trial coordinating centre (National Institute for Health Innovation).
Provenance and peer review Not commissioned; externally peer reviewed.
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