Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
PROtease modulating dressings in the treatment of chronic wounds: finding bioMARKers to predict healing response
Acronym
ProMark
Study hypothesis
A chronic leg ulcer is defined as a wound between the knee and ankle joint that has not healed within four weeks. The aim of this study is to identify biomarkers which differentiate between leg ulcer patients whose wounds will and will not respond to treatment with protease modulating dressings.
Ethics approval
Original protocol: Leeds (West) Research Ethics Committee, 07/09/2006, ref: 06/Q1205/155
Version 2.0: 19/10/2006
Version 3.0: 17/05/2007
Study design
Prospective multi-centre cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Not specified
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Chronic leg ulcer
Intervention
Patients will be randomised to receive 12 weeks therapy with either:
1. PROMOGRAN™ Wound Modulating Matrix
2. PROMOGRAN PRISMA™ Wound Balancing Matrix
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Response to treatment defined as either a more than or equal to 50% wound area reduction from the baseline to the 12 week wound area measurements or complete healing by 12 weeks
Secondary outcome measures
1. Initial response to treatment at 6 weeks defined a more than or equal to 50% wound area reduction from the baseline to the 6 week wound area measurements or complete healing by 6 weeks
2. Percentage baseline wound area reduction by 12 weeks
3. Safety - serious adverse events
Overall trial start date
01/03/2007
Overall trial end date
30/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18 or over with a venous leg ulcer
2. Duration of ulcer greater than or equal to 30 days
3. Ulcer greater than or equal to 1 cm^2 in area
4. Ankle Brachial Pressure Index (ABPI) greater than or equal to 0.80
5. Written informed consent
6. Able to comply with study treatment and follow-up schedule
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
Current exclusion criteria as of 07/07/2008:
1. Participating in another wound related study or intervention trial
2. Clinical signs of an infection of the target ulcer
3. Sharp debridement within past seven days
4. Pre-study (one month) treatment with therapies which affect wound healing including immunosuppressive therapy, dialysis, systemic corticosteroids, radiation therapy, chemotherapy, vascular or plastic surgery to the affected limb
5. Expected to require treatment with therapies which affect wound healing including immunosuppressive therapy, dialysis, systemic corticosteroids, radiation therapy or chemotherapy during the study period
6. Planned or expected to require vascular or plastic surgery to the affected limb, during the study period
7. Pre-study use (at any time) of the study dressings (PROMOGRAN™ Matrix and/or PROMOGRAN™ PRISMA Matrix)
8. Pre-study (one month) use of Active Wound Care Therapies
9. Pre-study (one week) use of silver-based products, larval therapy, iodine/povidone-iodine products, enzymatic debriding agents, topical corticosteroids, topical antibiotics, topical antifungal treatments, or antimicrobial agents (cleansing agents/dressings/topical treatments)
10. Known hypersensitivity to any of the dressing components
11. Life expectancy less than six months
Previous exclusion criteria:
1. Participating in another wound related study or intervention trial
2. Diabetes
3. Clinical signs of an infection of the target ulcer
4. Sharp debridement within past seven days
5. Pre-study (one month) treatment with therapies which affect wound healing including immunosuppressive therapy, dialysis, systemic corticosteroids, radiation therapy, chemotherapy, vascular or plastic surgery to the affected limb
6. Expected to require treatment with therapies which affect wound healing including immunosuppressive therapy, dialysis, systemic corticosteroids, radiation therapy or chemotherapy during the study period
7. Planned or expected to require vascular or plastic surgery to the affected limb, during the study period
8. Pre-study use (at any time) of the study dressings (PROMOGRAN™ Matrix and/or PROMOGRAN™ PRISMA Matrix)
9. Pre-study (one month) use of Active Wound Care Therapies
10. Pre-study (one week) use of silver-based products, larval therapy, iodine/povidone-iodine products, enzymatic debriding agents, topical corticosteroids, topical antibiotics, topical antifungal treatments, or antimicrobial agents (cleansing agents/dressings/topical treatments)
11. Known hypersensitivity to any of the dressing components
12. Life expectancy less than six months
Recruitment start date
01/03/2007
Recruitment end date
30/12/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Leeds
Leeds
LS2 9NG
United Kingdom
Sponsor information
Organisation
Johnson & Johnson Wound Management (UK)
Sponsor details
Johnson and Johnson Medical Ltd
Airebank Mills
Gargrave
Skipton
North Yorkshire
BD23 3RX
United Kingdom
Sponsor type
Industry
Website
http://www.jnjgateway.com/home.jhtml?loc=GBENG&page=viewContent&contentId=09008b98804404e4
Funders
Funder type
Industry
Funder name
Yorkshire Forward (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Johnson & Johnson Wound Management (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary