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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02896725
Ethics application status
Date submitted
29/08/2016
Date registered
12/09/2016

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
Timepoint [3] 0 0
24 weeks
Secondary outcome [4] 0 0
Change in health-related quality of life (generic)
Timepoint [4] 0 0
24 weeks
Secondary outcome [5] 0 0
Change in health-related quality of life (generic)
Timepoint [5] 0 0
24 weeks
Secondary outcome [6] 0 0
Change in health-related quality of life (disease-specific)
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2019
Sample size
Target
Accrual to date
Final
143
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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymised individual participant data may be made available on request to the Principal Investigator
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02896725