NCT01348581已完成不适用
Chronic Wound Treatment With Extracellular Matrix (ECM) Scaffold Made From Fish Proteins
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Kerecis Ltd.
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Wound healing
研究概览
简要总结
The clinical study is designed to assess the effectiveness, safety and non-immunogenicity of fish skin wound dressing extracellular matrix (ECM) in treating chronic wounds.
The wound dressing is indicated for the management of difficult to heal and chronic wounds. The matrix is cut to fit the wound and is applied to the wound bed. An absorptive secondary dressing is put on top. Further dressing of the wound depends on the etiology.
The indications for use are:
- partial and full-thickness wounds
- pressure ulcers
- venous ulcers
- diabetic ulcers
- chronic vascular ulcers
- tunneled/undermined wounds
- trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Venous leg ulcer
- •Arterial leg ulcer
- •Rheumatic leg ulcer
- •Hydrostatic leg ulcer
- •Ulcer where healing is delayed because of drug therapy
- •Non-healing ulcer due to known or unknown causes
排除标准
- •Active infection
结局指标
主要结局
Wound healing
时间窗: one year
次要结局
- Wound granulation(one year)
研究者
研究点 (2)
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