Urokinase Therapy in Diabetic Foot Syndrome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Foot, Arterial Occlusive Disease, Ischemia

Intervention / Treatment
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* Drug: Urokinase


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Interventional group | Drug: Urokinase<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients being alive, having no major amputation and healed ulceration |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Each of overall survival, major amputation rate, survival free of major amputation rate, rate of ulcer healing, and safety |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urokinase, diabetes, wound healing, major amputation