NCT00537498

Urokinase Therapy in Diabetic Foot Syndrome

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: medac GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Diabetic Foot
• Arterial Occlusive Disease
• Ischemia

Interventions

Type	Name	Description
DRUG	Urokinase	Daily intravenous application of urokinase over 30 minutes Dosage: If plasma fibrinogen is \> 2,5g/l application of 1 000 000 IU Urokinase If plasma fibrinogen is \< 2,5g/l application of 500 000 IU Urokinase If plasma fibrinogen is \< 1,6g/l treatment must be stopped and continued after rising up to \>2g/l

Timeline

• Start date: 2002-02-01
• Completion: 2006-12-01
• First posted: 2007-10-01
• Last updated: 2010-03-25

Locations

1 site across 1 country: Germany