Urokinase Therapy in Diabetic Foot Syndrome

NCT ID: NCT00537498

Last Updated: 2010-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2006-12-31

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.

Conditions

Diabetic Foot; Arterial Occlusive Disease; Ischemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Interventional group

Group Type: EXPERIMENTAL

Urokinase

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

medac GmbH

INDUSTRY

Sponsor Role: lead

Principal Investigators

Sebastian M. Schellong, Professor

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Carl Gustav Carus TU Dresden UniversitätsGefäßcentrum

Locations

Universitätsklinikum Carl Gustav Carus UniversitätsGefäßcentrum

Dresden, , Germany

Countries

Germany

Other Identifiers

MC-UK.2/AVK

Identifier Type: -

Identifier Source: org_study_id