ISRCTN35502943已完成未知
PROtease modulating dressings in the treatment of chronic wounds: finding bioMARKers to predict healing response
Johnson & Johnson Wound Management (UK)0 个研究点目标入组 120 人开始时间: 2006年8月11日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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