Urokinase Therapy in Diabetic Foot Syndrome

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: medac GmbH

Criteria

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