Urokinase Therapy in Patients With Diabetic Foot Syndrome

Medac

Status and phase: Terminated; Phase 3

Conditions: Diabetic Foot; Ischemia; Arterial Occlusive Disease

Treatments: Drug: Urokinase; Procedure: standard therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00823225

EudraCT number 2007-005916-15

MC-UK.3/AVK

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

A: Standard therapy

Other group

Treatment:

Procedure: standard therapy

B: Urokinase

Experimental group

Treatment:

Drug: Urokinase