Urokinase Therapy in Patients With Diabetic Foot Syndrome

Phase 3

Terminated

• Conditions: Diabetic Foot; Ischemia; Arterial Occlusive Disease
• Interventions: Procedure: standard therapy; Drug: Urokinase

• Registration Number: NCT00823225
• Lead Sponsor: medac GmbH

Brief 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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-01-14
• Study First Submitted QC: 2009-01-14
• Study First Posted: 2009-01-15
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-12
• Last Update Posted: 2015-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: Standard therapy	standard therapy	-
B: Urokinase	Urokinase	-

Primary Outcome Measures

Name	Time	Method
Major amputation free survival	Within twelve months after randomisation

Secondary Outcome Measures

Name	Time	Method
Total survival, major amputation rate, rate of complete ulcer healing, rate of adverse events	Within twelve month after randomisation

Trial Locations

Locations (6)

Franziskus Krankenhaus; 🇩🇪 Berlin, Germany

Klinikum Dortmund Nord GmbH; 🇩🇪 Dortmund, Germany

Klinikum Karlsbad Langensteinbach; 🇩🇪 Karlsbad, Germany

Krankenhaus Dresden-Neustadt; 🇩🇪 Dresden, Germany

Weißeritztal-Kliniken GmbH; 🇩🇪 Freital, Germany

Universitätsklinik; 🇩🇪 Dresden, Germany