Urokinase Therapy in Diabetic Foot Syndrome

medac GmbH77 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Foot Arterial Occlusive Disease Ischemia

Interventions

UrokinaseDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitätsklinikum Carl Gustav Carus UniversitätsGefäßcentrum

Dresden, Germany

Outcomes

Primary Outcomes

Number of patients being alive, having no major amputation and healed ulceration

Time frame: 12 months

Secondary Outcomes

Each of overall survival, major amputation rate, survival free of major amputation rate, rate of ulcer healing, and safety

Time frame: 12 months

Data from ClinicalTrials.gov

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