NCT01612806终止不适用
A Multi-center, Prospective, Randomized Study With PriMatrix Dermal Repair Scaffold, PriMatrix Ag Antimicrobial Dermal Repair Scaffold, and Standard of Care for the Treatment of Venous Leg Ulcers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 10
- 主要终点
- Percent of VLUs healed by week 12 post-randomization
研究概览
简要总结
To evaluate the effectiveness of PriMatrix, PriMatrix Ag, and Standard of Care in the treatment of venous leg ulcers (VLUs).
详细描述
Healing percentages
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
- •Men or women ≥ 18 years of age
- •Ankle-brachial index (ABI) > 0.80
- •Study wound 2-64 cm2 surface area
- •Wound does not exhibit a greater than 50% reduction in surface area during the screening period
排除标准
- •Suspected or confirmed signs/symptoms of wound infection
- •Hypersensitivity to bovine collagen
- •Body Mass Index (BMI) ≥ 45
结局指标
主要结局
Percent of VLUs healed by week 12 post-randomization
时间窗: 12 weeks
次要结局
- Cost of treatment(12 weeks)
研究者
研究点 (10)
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