Urokinase Therapy in Diabetic Foot Syndrome

Phase 2

Completed

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

• Registration Number: NCT00537498
• Lead Sponsor: medac GmbH

Brief 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.

Study Timeline

• Study Start: 2002-02
• Study Completion: 2006-12
• Status Verified: 2007-09
• Study First Submitted: 2007-09-28
• Study First Submitted QC: 2007-09-28
• Study First Posted: 2007-10-01
• Last Update Submitted: 2010-03-24
• Last Update Posted: 2010-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Urokinase	Interventional group

Primary Outcome Measures

Name	Time	Method
Number of patients being alive, having no major amputation and healed ulceration	12 months

Secondary Outcome Measures

Name	Time	Method
Each of overall survival, major amputation rate, survival free of major amputation rate, rate of ulcer healing, and safety	12 months

Trial Locations

Locations (1)

Universitätsklinikum Carl Gustav Carus UniversitätsGefäßcentrum; 🇩🇪 Dresden, Germany