Insufficient recruitment of study patients

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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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