Low Dose Urokinase Therapy in Patients With Diabetic Foot Syndrome and Critical Limb Ischemia Versus Conventional Standard Therapy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- medac GmbH
- 入组人数
- 5
- 试验地点
- 6
- 主要终点
- Major amputation free survival
研究概览
简要总结
The purpose of this study is to determine whether the additional therapy with low dose urokinase is more effective than only a conventional standard therapy concerning ulcer-healing, rate of major amputation and survival.
详细描述
Patients with diabetic foot ulceration and critical limb ischemia have a high risk of major amputation, especially if limbs can not be revascularized. Urokinase is effective in critical limb ischemia by lowering fibrinogen and might improve outcomes. The effect and safety of urokinase treatment was investigated in a phase II clinical trial. Based on the results this trial was planned to investigate the effect and safety of an additional therapy with urokinase versus a single conventional therapy.
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
- 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
- •Diabetic patients with angiopathic or angioneuropathic diabetic foot syndrome and criticial limb ischemia
- •No surgical or interventional treatment option
- •No healing tendency of ulcerations despite of antibiosis and wound debridement after two-week treatment
- •Fibrinogen > 4.0 g/l
- •No previous major amputation
排除标准
- •Prior treatment of the current ulceration with urokinase
- •Need for dialysis and/or creatinine-clearance < 20ml/min
- •INR > 1,5 at screening
- •Any kind of cerebral event within 3 months prior inclusion
- •Proliferative retinopathy
- •Uncontrolled hypertension
- •Hemorraghic diathesis
- •Gastrointestinal bleeding
- •Pregnancy
- •No compliance and/or participation in another trial
研究组 & 干预措施
A: Standard therapy
干预措施: standard therapy (Procedure)
B: Urokinase
干预措施: Urokinase (Drug)
结局指标
主要结局
Major amputation free survival
时间窗: Within twelve months after randomisation
次要结局
- Total survival, major amputation rate, rate of complete ulcer healing, rate of adverse events(Within twelve month after randomisation)