NCT01499472Unknown不适用
ESWT Treatment of Diabetic Foot VS. Standard Care Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- healed ulcer
研究概览
简要总结
The purpose of this study is to determine if Extra-corporeal-shockwave Therapy (ESWT) added to standard of care wound therapy significantly improves time to complete wound healing in diabetic foot wounds.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent.
- •Diagnosed with Diabetes.
- •An Active Diabetic Ulcer larger than 5 cm2
- •Sufficient limb perfusion.(e.g no compartment syndrome ankle Brachial Index (ABI)>=0.5
排除标准
- •The patient is under another research protocol.
- •One of the following:
- •A. ABI<0.5 C.Significant Arterial-Venous injury. D. Lymphedema.
- •The patient underwent Chemotherapy or Radiotherapy 60 days or less prior to recruitment date.
- •Sufficient Noncompliant.
- •Sickle Cell Anemia, HIV, Immunodeficiency, HgB Anemia, DVT, Chronic Renal Failure, Systemic use of Steroids
结局指标
主要结局
healed ulcer
时间窗: 6 months
次要结局
未报告次要终点
研究者
Ofer Elishuv
Doctor
Hadassah Medical Organization
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