Urokinase Therapy in Patients With Diabetic Foot Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-06-30

Brief Summary

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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.

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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 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.

Conditions

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Diabetic Foot Arterial Occlusive Disease Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A: Standard therapy

Group Type OTHER

standard therapy

Intervention Type PROCEDURE

wound debridement, moist wound dressing

B: Urokinase

Group Type EXPERIMENTAL

Urokinase

Intervention Type DRUG

Daily infusion up to 21 applications, dose dependent on fibrinogen level:

\> 2,5g/l 1 000 000 IU, \< 2,5g/l 500 000 IU

Interventions

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standard therapy

wound debridement, moist wound dressing

Intervention Type PROCEDURE

Urokinase

Daily infusion up to 21 applications, dose dependent on fibrinogen level:

\> 2,5g/l 1 000 000 IU, \< 2,5g/l 500 000 IU

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No