Prevention of Amputation in a High Risk Population With Comprehensive Care and Amniotic Tissue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Limb salvage
研究概览
简要总结
The purpose of this study is to see whether the use of AMNIOEXCEL® improves healing and reduces the need to cut off all or part of a leg (amputation) in high-risk patients who have diabetes and foot sores (also sometimes called ulcers or wounds).
详细描述
The purpose of this study is to demonstrate the effectiveness of comprehensive, interdisciplinary approach (usual care) in combination with early application of advanced therapy; dehydrated human amniotic membrane allografts (AMNIOEXCEL®, Derma Science, Princeton, New Jersey) in healing and preventing amputation in high risk patients with diabetic foot ulcers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 1 or 2 diabetes
- •Ulcer anywhere on the foot
- •Moderate to high risk for amputation according to Prevention of Amputation for Veterans Everywhere (PAVE) and the Society for Vascular Surgery Lower Extremity Threatened Limb (SVS WIfI) classification system (WIFi) criteria
排除标准
- •Inability or unwillingness to travel to Boise VA for clinic visits
- •Enrolled in Hospice
- •Have known or expected malignancy of foot ulcer
- •Are or planning to become pregnant
- •Signs of progressive gangrene, limb-threatening infection
结局指标
主要结局
Limb salvage
时间窗: One month past wound healing
All subjects will be seen weekly/biweekly by the study team until the point of definitive wound closure (epithelialization) and the subject has the ability to progress weight bearing and ambulation.
次要结局
- effective wound healing(One month past wound healing)
研究者
Margaret Doucette
Director, Physical Medicine and Rehabilitation
Boise VA Medical Center