Urokinase Therapy in Patients With Diabetic Foot Syndrome

Phase 3TerminatedNCT00823225

medac GmbH5 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Foot Arterial Occlusive Disease Ischemia

Interventions

standard therapyPROCEDURE

wound debridement, moist wound dressing

UrokinaseDRUG

Daily infusion up to 21 applications, dose dependent on fibrinogen level: \> 2,5g/l 1 000 000 IU, \< 2,5g/l 500 000 IU

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 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

Locations (6)

Franziskus Krankenhaus

Berlin, Germany

Klinikum Dortmund Nord GmbH

Dortmund, Germany

Krankenhaus Dresden-Neustadt

Dresden, Germany

Universitätsklinik

Dresden, Germany

Outcomes

Primary Outcomes

Major amputation free survival

Time frame: Within twelve months after randomisation

Secondary Outcomes

Total survival, major amputation rate, rate of complete ulcer healing, rate of adverse events

Time frame: Within twelve month after randomisation

Data from ClinicalTrials.gov

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