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Wool-derived Keratin Dressings for Venous Leg Ulcers

NCT02896725 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2020-07-24

No results posted yet for this study

Summary

Venous leg ulcers (VLU) are the most common leg ulcer, can be painful, and limit work, lifestyles and activity, especially in older patients. Compression bandaging is the main treatment but there are few added treatments for patients with slow healing VLU. About 50% of patients with VLU may be slow healing. Research suggests using keratin dressings as well as using compression may help healing in patients with show healing VLU, but the current evidence is not enough to change clinical practice. The investigators will conduct a randomised controlled trial to test whether using keratin dressings is better than usual care for slow healing VLU.

Conditions

  • Varicose Ulcer

Interventions

DEVICE

Keratin dressings

Wool-derived keratin matrix dressings applied with each change of the compression bandage until healing or the trial ends

DEVICE

Usual care dressings

Dressings chosen from study centres' formulary of non-medicated moist wound dressings (non-adherent dressings, hydrogel, alginate, hydrofibre or polyurethane foam dressings) applied with each change of the compression bandage until healing or the trial ends

Sponsors & Collaborators

  • Health Research Council, New Zealand

    collaborator OTHER

  • University of Auckland, New Zealand

    lead OTHER

Principal Investigators

  • Andrew Jull, RN PhD · National Institute for Health Innovation, University of Auckland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2019-02-28
Completion
2019-09-30

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02896725 on ClinicalTrials.gov