Chronic leg ulcer Skin and Connective Tissue Diseases Leg ulcer
Conditions
Interventions
Patients will be randomised to receive 12 weeks therapy with either:
1. PROMOGRAN™ Wound Modulating Matrix
2. PROMOGRAN PRISMA™ Wound Balancing Matrix
Sponsors
Johnson & Johnson Wound Management (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed