NCT01909908终止不适用
Treatment of Chronic Wounds Using Extracellular Matrix-Based Devices and the Patient's Own Blood Components
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The Extracellular Matrix (ECM) and Blood Components for Wound Healing feasibility study is a clinical trial approved by Health Canada to study the safety of extracellular matrix (ECM) and autologous blood products in wound healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Type 1 or Type 2 diabetes, and/or venous insufficiency to the affected leg
- •Ulcer has been present between 12 and 52 weeks
- •Ulcer is less than 40 cm2 in area
排除标准
- •Less than 18 years of age
- •Pregnant or planning to become pregnant during the study period
- •Simultaneously participating in another investigational drug or device study
- •Unable or unwilling to comply with the weekly study follow-up schedule or off-loading regimen
- •Patient or legal representative refuses to sign the EC-approved informed consent form
- •Known allergy to pig or porcine products
- •Additional criteria may apply
结局指标
主要结局
Incidence of adverse events
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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