NCT01228500撤回不适用
The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time to healing
研究概览
简要总结
The primary aim of this study proposal is to test an innovative form of fetal bovine dermis bioscaffold in combination with negative pressure wound therapy (NPWT) to enhance wound healing in diabetic foot ulcers.
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
- Double (Participant, Investigator)
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
- •Adult Type 1 or 2 diabetic patients that present with foot ulcers.
- •Ulcer size of at least 3 centimeters (cm) in diameter at its widest dimension.
- •Ulcer depth: Full thickness (absence of all epithelial layers or deeper)
- •Adequate perfusion (at least one palpable pedal pulse or pedal bypass graft)
- •All ulcer durations will be eligible
- •Patients currently receiving NPWT for a diabetic foot ulcer
- •Patients must be appropriate NPWT candidates and be willing and able to sleep, ambulate, and rest with the NPWT unit in place.
排除标准
- •Active foot infections
- •Presence of any serious disease including end-stage renal failure requiring dialysis or renal transplantation or active malignant disease requiring treatment which seriously compromises the patient's ability to complete this study
- •Patients who are pregnant
- •Allergies to any material contained within the NPWT or bioscaffold
- •Any condition that would exclude NPWT use including but not limited to active bleeding, presence of malignancy in the wound or inability to follow any of the NPWT safety guidelines
结局指标
主要结局
Time to healing
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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