Varicose UlcerKeratin4VLUNCT02896725
Wool-derived Keratin Dressings for Venous Leg Ulcers
A study testing Keratin dressings in people with Varicose Ulcer, run by University of Auckland, New Zealand at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Ulcer
- What is being tested?
- Keratin dressings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteNew Zealand
- Study dates
- 1 Mar 2017to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Severe liver, heart, or renal failure
- Severe peripheral arterial disease
- Suspected or diagnosed skin malignancy
- Other threat to safe participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Keratin4VLU: A Randomised Controlled Trial of Wool-derived Keratin Dressings for Venous Leg Ulcers
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.
Read the detailed description
A pragmatic, community based, single-blind, usual care-controlled, randomised trial to determine whether keratin dressings increase the proportion of patients with venous leg ulcers healed at 24 weeks when used in addition to compression in patients with slow healing venous leg ulcers. Participants in have compression therapy (system of choice guided by patient and/or clinical preference) as delivered through district nursing services at the study centres as a background treatment. Keratin dressings will be applied when the compression bandage is changed (approximately weekly). Usual care dressings will consist of the usual formulary of moist wound dressings available at each study centre.
Participants will be district nursing service patients in five study centres in New Zealand with prevalent or incident venous leg ulcers. A venous leg ulcer will be defined as a wound on the lower leg that has remained unhealed for 4 or more weeks, appears to be primarily venous in aetiology with other causative diseases ruled out. If the participant has two or more venous leg ulcers, the largest ulcer will be the reference ulcer. A participant will be considered to have a slow healing venous leg ulcer if the ulcer area is larger than 5 cm2 and/or the ulcer has been present for more than six months.
Participants will receive up to four visits from the research nurse - visit 1 to screen for eligibility, visit 2 to consent and randomise the participant, visits 3 and 4 to collect outcome data. District nurses will continue to visit the participant (about weekly or more frequently if required) to provide routine care between research nurse visits.
Block randomisation will be used, stratified by study centre and prognostic index (ulcer size greater than 5cm2 and/or ulcer duration greater than 6 months) to ensure a balance of participants within study centres and for participants likely to be slow healers. Research nurses will input information on inclusion criteria, exclusion criteria, and relevant clinical history on consented participants via a tablet computer. The allocation will be generated after this information has been entered. Randomised participants will receive the allocated treatment until the reference ulcer heals or data collection is completed, whichever occurs sooner.
- Conditions
- Varicose Ulcer
- Being tested
- Keratin dressings, Usual care dressings
- Keywords
- Venous leg ulcer, Acellular skin substitutes, Keratin dressings
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keratin dressingsDevice
Wool-derived keratin matrix dressings applied with each change of the compression bandage until healing or the trial ends
Usual care dressingsDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Keratin dressings | Experimental | Wool-derived keratin matrix dressing applied with each change of the compression bandage until healing Receives: 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 Receives: Device: Usual care dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with complete healing of reference ulcer
Measured: 24 weeks
Secondary outcomes (7)
Agreement between blinded and unblinded assessors on healing
Measured: 24 week outcome
Time to complete healing of reference ulcer
Measured: Until data collection completed two years after first participant is recruited
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.
Measured: 24 weeks
Change in health-related quality of life (generic)
The RAND-36 questionnaire will be used for measurement of generic health-related quality of life
Measured: 24 weeks
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
Measured: 24 weeks
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
Measured: 24 weeks
Incidence of adverse events
Measured: Until data collection completed two years after first participant is recruited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start1 Mar 2017
- Primary completion28 Feb 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Varicose UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants allocated to receive either keratin dressing or usual care dressing
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Council, New Zealand
- Responsible party
- Principal investigator, Andrew Jull, University of Auckland, New Zealand
- Investigators
- Andrew Jull, RN PhD, Principal investigator, National Institute for Health Innovation, University of Auckland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896725
- Sponsor's protocol ID
- Keratin4VLU
- Other IDs
- U1111-1186-5202
- Acronym
- Keratin4VLU
- Status last verified
- Jul 2020
- First submitted
- 29 Aug 2016
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised individual participant data may be made available on request to the Principal Investigator
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.
PubMed 29440219Jull 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.
PubMed 32690743
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keratin4VLU: A Randomised Controlled Trial of Wool-derived Keratin Dressings for Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT02896725
- Acronym / sponsor ID
- Keratin4VLU / Keratin4VLU
- Conditions
- Varicose Ulcer
- Keywords
- Venous leg ulcer, Acellular skin substitutes, Keratin dressings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Collaborators
- Health Research Council, New Zealand
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A pragmatic, community based, single-blind, usual care-controlled, randomised trial to determine whether keratin dressings increase the proportion of patients with venous leg ulcers healed at 24 weeks when used in addition to compression in patients with slow healing venous leg ulcers. Participants in have compression therapy (system of choice guided by patient and/or clinical preference) as delivered through district nursing services at the study centres as a background treatment. Keratin dressings will be applied when the compression bandage is changed (approximately weekly). Usual care dressings will consist of the usual formulary of moist wound dressings available at each study centre.
Participants will be district nursing service patients in five study centres in New Zealand with prevalent or incident venous leg ulcers. A venous leg ulcer will be defined as a wound on the lower leg that has remained unhealed for 4 or more weeks, appears to be primarily venous in aetiology with other causative diseases ruled out. If the participant has two or more venous leg ulcers, the largest ulcer will be the reference ulcer. A participant will be considered to have a slow healing venous leg ulcer if the ulcer area is larger than 5 cm2 and/or the ulcer has been present for more than six months.
Participants will receive up to four visits from the research nurse - visit 1 to screen for eligibility, visit 2 to consent and randomise the participant, visits 3 and 4 to collect outcome data. District nurses will continue to visit the participant (about weekly or more frequently if required) to provide routine care between research nurse visits.
Block randomisation will be used, stratified by study centre and prognostic index (ulcer size greater than 5cm2 and/or ulcer duration greater than 6 months) to ensure a balance of participants within study centres and for participants likely to be slow healers. Research nurses will input information on inclusion criteria, exclusion criteria, and relevant clinical history on consented participants via a tablet computer. The allocation will be generated after this information has been entered. Randomised participants will receive the allocated treatment until the reference ulcer heals or data collection is completed, whichever occurs sooner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants allocated to receive either keratin dressing or usual care dressing
| Arm | Type | Receives |
|---|---|---|
| Keratin dressings | Experimental | Device: Keratin dressingsWool-derived keratin matrix dressing applied with each change of the compression bandage until healing |
| Usual care dressings | Active comparator | Device: Usual care dressingsDressing chosen from study centres' formulary of non-medicated moist wound dressings applied with each change of the compression bandage until healing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Keratin dressingsWool-derived keratin matrix dressings applied with each change of the compression bandage until healing or the trial ends | Device | Keratin dressings |
| Usual care dressingsDressings 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 | Device | Usual care dressings |
Primary outcome
Proportion of patients with complete healing of reference ulcer
Time frame: 24 weeks
7 secondary outcomes
Agreement between blinded and unblinded assessors on healing
Time frame: 24 week outcome
Time to complete healing of reference ulcer
Time frame: Until data collection completed two years after first participant is recruited
Change in estimated reference ulcer area
Time frame: 24 weeks
Change in health-related quality of life (generic)
Time frame: 24 weeks
Change in health-related quality of life (generic)
Time frame: 24 weeks
Change in health-related quality of life (disease-specific)
Time frame: 24 weeks
Incidence of adverse events
Time frame: Until data collection completed two years after first participant is recruited
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Background: PubMed 29440219Jull 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.
- Derived from this study: PubMed 32690743Jull 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.
- Individual participant dataSharing planned: Yes. Anonymised individual participant data may be made available on request to the Principal Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Jull, RN PhD principal investigator
National Institute for Health Innovation, University of Auckland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keratin dressings in people with Varicose Ulcer, run by University of Auckland, New Zealand at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with complete healing of reference ulcer (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02896725, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.