Urokinase Therapy in Diabetic Foot Syndrome

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537498
• Other study ID #: MC-UK.2/AVK
• Status: Completed
• Phase: Phase 2
• First received: September 28, 2007
• Last updated: March 24, 2010
• Start date: February 2002
• Est. completion date: December 2006

Study information

• Verified date: September 2007
• Source: medac GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Disease
• Arterial Occlusive Diseases
• Diabetic Foot
• Ischemia

Intervention

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

Locations

Country	Name	City	State
Germany	Universitätsklinikum Carl Gustav Carus UniversitätsGefäßcentrum	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
medac GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients being alive, having no major amputation and healed ulceration		12 months
Secondary	Each of overall survival, major amputation rate, survival free of major amputation rate, rate of ulcer healing, and safety		12 months