Urokinase Therapy in Diabetic Foot Syndrome

Medac

Status and phase

Completed

Phase 2

Conditions

Diabetic Foot

Ischemia

Arterial Occlusive Disease

Treatments

Drug: Urokinase

Study type

Interventional

Funder types

Industry

Identifiers

NCT00537498

MC-UK.2/AVK

Details and patient eligibility

About

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.

Full 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.

Enrollment

77 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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