NCT00823225

Urokinase Therapy in Patients With Diabetic Foot Syndrome

Low Dose Urokinase Therapy in Patients With Diabetic Foot Syndrome and Critical Limb Ischemia Versus Conventional Standard Therapy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: medac GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Diabetic Foot
• Arterial Occlusive Disease
• Ischemia

Interventions

Type	Name	Description
PROCEDURE	standard therapy	wound debridement, moist wound dressing
DRUG	Urokinase	Daily infusion up to 21 applications, dose dependent on fibrinogen level: \> 2,5g/l 1 000 000 IU, \< 2,5g/l 500 000 IU

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2009-01-15
• Last updated: 2015-03-13

Locations

6 sites across 1 country: Germany