An Evaluation of Tissue Engineering Approaches for Treatment of Neuropathic Diabetic Foot Ulcers Resistant to Standard of Care: A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 18
- 主要终点
- Number of Participants With Complete Wound Closure
研究概览
简要总结
The primary objective of this study is to assess the effectiveness of MatriStem devices compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic foot ulcers.
详细描述
Due to their characteristically poor healing capacity, diabetic foot ulcers (DFUs) are challenging for clinicians to treat. This prospective, multi-center clinical study will examine outcomes following treatment of DFUs, with one of two FDA cleared tissue-engineered devices, MatriStem® or cellular dermal replacement tissue, on DFUs that have demonstrated an inadequate response to initial standard of care therapy. The incidence of ulcer closure, rate of wound closure, and quality of life will be evaluated over a eight week period.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a current diagnosis of type I or type II diabetes
- •Subject's ulcer is on the forefoot or heel
- •Subject has chronic ulcer - has been present for minimum of 4 weeks
- •Subject's ulcer extends through the dermis and into the subcutaneous tissue
- •Subject's HgbA1c <12%
- •Subject has adequate circulation to the study foot as evidenced by a Doppler measured ABI greater than or equal to 0.7after 10 minutes rest
排除标准
- •Subject has a known sensitivity to bovine- or porcine-derived products.
- •Subject's ulcer is due to a non-diabetic etiology
- •Subject's ulcer is over a Charcot deformity of the mid-foot
- •Subject's random blood sugar readings are >450 mg/dL
- •Subject is on dialysis
- •Subject has a non-study ulcer on the study limb located within 7.0 cm of the study ulcer
结局指标
主要结局
Number of Participants With Complete Wound Closure
时间窗: 8 Weeks
Number of participants with incidence of complete wound closure
次要结局
未报告次要终点