The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02896725




Registration number
NCT02896725
Ethics application status
Date submitted
29/08/2016
Date registered
12/09/2016
Date last updated
3/04/2019

Titles & IDs
Public title
Wool-derived Keratin Dressings for Venous Leg Ulcers
Scientific title
Keratin4VLU: A Randomised Controlled Trial of Wool-derived Keratin Dressings for Venous Leg Ulcers
Secondary ID [1] 0 0
U1111-1186-5202
Secondary ID [2] 0 0
Keratin4VLU
Universal Trial Number (UTN)
Trial acronym
Keratin4VLU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Varicose Ulcer 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Skin 0 0 0 0
Other skin conditions
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Keratin dressings
Treatment: Devices - Usual care dressings

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

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


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

Treatment: Devices: 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

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients with complete healing of reference ulcer
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Agreement between blinded and unblinded assessors on healing
Timepoint [1] 0 0
24 week outcome
Secondary outcome [2] 0 0
Time to complete healing of reference ulcer
Timepoint [2] 0 0
Until data collection completed two years after first participant is recruited
Secondary outcome [3] 0 0
Change in estimated reference ulcer area - Estimated ulcer area will be derived measuring maximum width and length to determine area using formula for area of an ellipse. Such an approach is highly co-related (r=0.92) with more sophisticated measurement methods.
Timepoint [3] 0 0
24 weeks
Secondary outcome [4] 0 0
Change in health-related quality of life (generic) - The RAND-36 questionnaire will be used for measurement of generic health-related quality of life
Timepoint [4] 0 0
24 weeks
Secondary outcome [5] 0 0
Change in health-related quality of life (generic) - The EuroQuol-5D questionnaire will be used to generate utility values for cost-effectiveness modelling should that be undertaken
Timepoint [5] 0 0
24 weeks
Secondary outcome [6] 0 0
Change in health-related quality of life (disease-specific) - The Charing Cross Venous Ulcer Questionnaire will be used for measurement of disease-specific health-related quality of life
Timepoint [6] 0 0
24 weeks
Secondary outcome [7] 0 0
Incidence of adverse events
Timepoint [7] 0 0
Until data collection completed two years after first participant is recruited

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Health Research Council, New Zealand
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02896725
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Jull, RN PhD
Address 0 0
National Institute for Health Innovation, University of Auckland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications