Urokinase Therapy in Diabetic Foot Syndrome

Phase II Study of Urokinase Therapy for Treatment of Angiopathic or Angioneuropathic Diabetic Foot Syndrome

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.

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.

Inclusion Criteria:

• angiopathic or angioneuropathic diabetic foot lesions
• critical limb ischemia
• no surgical or interventional treatment option

Exclusion Criteria:

• 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