Urokinase Therapy in Patients With Diabetic Foot Syndrome

• Status: Terminated
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: medac GmbH

Criteria

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