PROtease modulating dressings in the treatment of chronic wounds: finding bioMARKers to predict healing response

Not Applicable

Completed

• Conditions: Chronic leg ulcer; Skin and Connective Tissue Diseases; Leg ulcer

• Registration Number: ISRCTN35502943
• Lead Sponsor: Johnson & Johnson Wound Management (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-11
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified