NCT03708029终止不适用
A Clinical Investigation Into the Efficacy of Full-thickness Human Placental Graft (Revita) in Diabetic Foot Ulcers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- StimLabs
- 入组人数
- 9
- 试验地点
- 6
- 主要终点
- Complete Wound Closure
研究概览
简要总结
To determine the efficacy of full-thickness placental allograft in chronic wound healing
详细描述
To evaluate the efficacy of Revita full thickness placental allograft in improving wound closure rates and mean closure time in diabetic foot ulcers (DFUs) as compared to the current standards of wound care treatment
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients
- •18-80 years old
- •Diagnosis of Type 1 or 2 Diabetes Mellitus
- •Foot ulcers >1cm2 and <25cm2 for 4 weeks or more prior to enrollment
- •Able to give consent to participate
- •Compliance with all aspects of protocol and follow-up
排除标准
- •Male and female patients younger than 18 years old
- •Male or female patients older than 80 years old
- •Smoking, and any additional health risk factors contraindicated with Revita use
- •Involvement in any other ongoing studies
结局指标
主要结局
Complete Wound Closure
时间窗: 12 weeks
100% epithelization
次要结局
- Percent(%) Healed(12 weeks)
研究者
研究点 (6)
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