Phase II Study of Urokinase Therapy for Treatment of Angiopathic or Angioneuropathic Diabetic Foot Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- medac GmbH
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Number of patients being alive, having no major amputation and healed ulceration
研究概览
简要总结
The purpose of this study is to evaluate whether a treatment with urokinase (500 000 or 1 000 000 IU) can lead to ulcer-healing, lower rate of major amputation, and prolonged survival in patients with diabetic foot syndrome.
详细描述
Patients with diabetic foot ulceration and critical limb ischemia have a high risk of major amputation especially if limbs cannot be revascularized. Urokinase is effective in improving the microcirculation in critical limb ischemia by lowering fibrinogen and might improve outcomes. There are however no data on the efficacy and safety of urokinase treatment in terms of survival free of major amputation, ulcer healing and the rate of minor and major bleeding. Therefore this trial is conducted to investigate the effect of urokinase treatment on these parameters.
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
- None
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
- •angiopathic or angioneuropathic diabetic foot lesions
- •critical limb ischemia
- •no surgical or interventional treatment option
排除标准
- •feasibility of vascular surgery or angioplasty
- •prior treatment of the current ulceration with urokinase
- •need for dialysis
- •creatinine > 180µmol/l
- •any kind of cerebral event less than three months before inclusion into the study
- •proliferative retinopathy (not remediated)
- •uncontrolled hypertension
- •hemorrhagic diathesis
- •gastrointestinal bleeding
- •need for oral anticoagulation
- •mental disorders
- •pregnancy
- •participation in another study
研究组 & 干预措施
1
Interventional group
干预措施: Urokinase (Drug)
结局指标
主要结局
Number of patients being alive, having no major amputation and healed ulceration
时间窗: 12 months
次要结局
- Each of overall survival, major amputation rate, survival free of major amputation rate, rate of ulcer healing, and safety(12 months)