NCT01228526已完成不适用
A Multicenter, Prospective, Observational Study With PriMatrix for the Treatment of Neuropathic Diabetic Foot Ulcers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 5
- 主要终点
- Percent of study ulcers healed
研究概览
简要总结
To evaluate the effectiveness of PriMatrix in the treatment of DFUs in subjects without significantly compromised arterial circulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 I or Type II diabetes with investigator-confirmed reasonable metabolic control
- •Peripheral neuropathy
- •A full thickness diabetic plantar foot ulcer of at least 1 cm2 but not exceeding 10 cm2 in area
- •An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening
排除标准
- •Suspected or confirmed signs/symptoms of wound infection
- •Wounds with exposed bone or tendon
- •Hypersensitivity to bovine collagen
结局指标
主要结局
Percent of study ulcers healed
时间窗: Week 12
次要结局
未报告次要终点
研究者
研究点 (5)
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