Wool-derived Keratin Dressings for Venous Leg Ulcers

NCT02896725 | Completed DMC

• 2 other identifiers: Keratin4VLUU1111-1186-5202
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Venous leg ulcer; Acellular skin substitutes; Keratin dressings

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with complete healing of reference ulcer

  24 weeks

Secondary Outcomes (7)

• Agreement between blinded and unblinded assessors on healing

  24 week outcome

• Time to complete healing of reference ulcer

  Until data collection completed two years after first participant is recruited

• Change in estimated reference ulcer area

  24 weeks

• Change in health-related quality of life (generic)

  24 weeks

• Change in health-related quality of life (generic)

  24 weeks

Study Arms (2)

Keratin dressings

EXPERIMENTAL

Wool-derived keratin matrix dressing applied with each change of the compression bandage until healing

Device: Keratin dressings

Usual care dressings

ACTIVE COMPARATOR

Dressing chosen from study centres' formulary of non-medicated moist wound dressings applied with each change of the compression bandage until healing

Device: Usual care dressings

Interventions

Keratin dressings DEVICE

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

Keratin dressings

Usual care dressings DEVICE

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

Usual care dressings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical indications of venous leg ulceration
• Ankle Brachial Index ≥ 0.7
• Able to tolerate compression therapy
• Ulcer area \> 5cm2 and/or ulcer duration \> 6 months
• Able to provide informed consent.

You may not qualify if:

• Hypersensitivity to wool or wool alcohols
• Venous leg ulceration with exposed tendon or bone
• Infected venous leg ulcer at trial inception (eligible after infection resolved)
• Venous leg ulcer with critical bioburden at trial inception (eligible if resolved)
• History of rheumatoid arthritis or vasculitis
• Uncontrolled diabetes
• Severe liver, heart, or renal failure
• Severe peripheral arterial disease
• Suspected or diagnosed skin malignancy
• Other threat to safe participation.

Sponsors & Collaborators

• University of Auckland, New Zealand: lead
• Health Research Council, New Zealand: collaborator

Study Sites (1)

University of Auckland

Auckland, New Zealand

Location

Related Publications (2)

• Jull A, Wadham A, Bullen C, Parag V, Waters J. Wool-derived keratin dressings versus usual care dressings for treatment of slow-healing venous leg ulceration: study protocol for a randomised controlled trial (Keratin4VLU). BMJ Open. 2018 Feb 13;8(2):e020319. doi: 10.1136/bmjopen-2017-020319.

  PMID: 29440219 BACKGROUND

• Jull A, Wadham A, Bullen C, Parag V, Weller C, Waters J. Wool-derived keratin dressings versus usual care dressings for treatment of slow healing venous leg ulceration: a randomised controlled trial (Keratin4VLU). BMJ Open. 2020 Jul 20;10(7):e036476. doi: 10.1136/bmjopen-2019-036476.

  PMID: 32690743 DERIVED

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andrew Jull, RN PhD

  National Institute for Health Innovation, University of Auckland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Healing status for primary and secondary outcomes are adjudicated by blinded review of photographs of healed reference ulcer site or unhealed reference
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants allocated to receive either keratin dressing or usual care dressing

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 12, 2016
• Study Start: March 1, 2017
• Primary Completion: February 28, 2019
• Study Completion: September 30, 2019
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share

Locations

NZ (1)