PROtease modulating dressings in the treatment of chronic wounds: finding bioMARKers to predict healing response
| ISRCTN | ISRCTN35502943 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35502943 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/06/2006
- Registration date
- 11/08/2006
- Last edited
- 07/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jane Nixon
Scientific
Scientific
Clinical Trials Research Unit
University of Leeds
17 Springfield Mount
Leeds
LS2 9NG
United Kingdom
Study information
| Study design | Prospective multi-centre cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Not specified |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | PROtease modulating dressings in the treatment of chronic wounds: finding bioMARKers to predict healing response |
| Study acronym | ProMark |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/03/2007 |
| Completion date | 30/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 30/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Leeds
Leeds
LS2 9NG
United Kingdom
LS2 9NG
United Kingdom
Sponsor information
Johnson & Johnson Wound Management (UK)
Industry
Industry
Johnson and Johnson Medical Ltd
Airebank Mills
Gargrave, Skipton
North Yorkshire
BD23 3RX
United Kingdom
| Website | http://www.jnjgateway.com/home.jhtml?loc=GBENG&page=viewContent&contentId=09008b98804404e4 |
|---|---|
"ROR" |
https://ror.org/03qwpn290 |
Funders
Funder type
Industry
Yorkshire Forward (UK)
No information available
Johnson & Johnson Wound Management (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
12/02/2008: The overall trial end date was amended and approved; the previous dates are as follows:
Original overall trial start date: 01/09/2006
Original overall trial end date: 30/06/2007
Amended overall trial start date 1 (amended 19/02/2007): 01/03/2007
Amended overall trial end date 1 (amended 19/02/2007): 01/10/2007
