Patients With Diabetic Foot Syndrome and Critical Limb Ischemia - a Randomized Clinical Trial With Urokinase
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- GWT-TUD GmbH
- 入组人数
- 34
- 试验地点
- 18
- 主要终点
- Duration of survival without major amputation in urokinase group compared to group with standard therapy
研究概览
简要总结
In this randomized clinical trial (RCT) the investigators are trying to find out whether a low-dose therapy with daily short infusions of urokinase using 10 to 21 doses over a maximum of 30 days is capable of prolonging the survival time without major amputation.
详细描述
August-2 is a trial embedded in the August-1 registry study. All patients enrolled in August-2 are also part of August-1, but there will be patients who are documented in the register, but will not take part in August-2. The investigators want to find out to which extent the patients in the registry are representative to the overall population suffering from this condition and how the therapeutic success of other therapy regimes can be described.
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
- •age 18 years or older
- •angiopathic or angioneuropathic critical limb ischemia (at least Wagner-Armstrong stadium II)
- •participation in the August-1 Register
- •revascularization not possible or residual ischemia after revascularization
- •persisting ulcerations despite antibiosis, adjustment of blood glucose levels and debridement
- •expected further hospitalization for at least 3 weeks (pressure relief and antibiosis)
- •fibrinogen >= 4g/l
- •signed informed consent
排除标准
- •life expectancy < 1 year
- •prior major amputation
- •planned major amputation
- •prior therapy of the current episode of diabetic foot syndrome with urokinase (except in cases of revascularization when the duration between the intervention and randomization must not exceed 7 days)
- •mechanical heart valve substitute
- •cerebral event with CT-detectable changes in the last 3 months
- •non-remediated proliferation retinopathy
- •uncontrolled hypertension (systolic >180 mmg, diastolic >100 mmHg)
- •hemorrhagic diathesis (spontaneous quick < 50%, spontaneous PTT > 40 s, thrombocytes < 100 Gpt/l)
- •gastrointestinal bleeding or ulcers in the last 4 weeks
- •prior reverse bypass operation
- •contraindications against therapy with urokinase acc. to the SMPc
- •concurrent participation in another clinical trial
- •insufficient compliance
- •pregnancy
研究组 & 干预措施
urokinase
patients receiving urokinase short infusions in addition to standard therapy
干预措施: urokinase (Drug)
结局指标
主要结局
Duration of survival without major amputation in urokinase group compared to group with standard therapy
时间窗: within the FU of 12 months
次要结局
- total mortality(12 months after randomization)
- minor amputation(12 months after randomization)
- Number of necessary revisions in case of minor amputation(12 months after randomization)
- complete healing of targeted lesion(within the FU of 12 months)
- new lesions on previously affected leg(within the FU of 12 months)
- efficacy in dialysis patients(within the FU of 12 months)
- duration of hospital stay(from baseline examination until first release (expected average of 2 weeks in general))
- re-hospitalization after dismissal following end of therapy with urokinase(within the FU of 12 months)
- Necessity for parenteral therapy with vasoactive substances(from baseline to end of 12 months FU)
- cardiovascular events(from baseline to end of 12 months FU)
- incidence and type of bleeding events(from randomization until day 33)
- incidence and type of other adverse events(from baseline to end of 12 months FU)
- new lesions on the contralateral leg(within the FU of 12 months)