Status:
TERMINATED
Urokinase Therapy in Patients With Diabetic Foot Syndrome
Lead Sponsor:
medac GmbH
Conditions:
Diabetic Foot
Arterial Occlusive Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 amp...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00823225
Start Date
June 1 2008
End Date
June 1 2009
Last Update
March 13 2015
Active Locations (6)
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1
Franziskus Krankenhaus
Berlin, Germany
2
Klinikum Dortmund Nord GmbH
Dortmund, Germany
3
Krankenhaus Dresden-Neustadt
Dresden, Germany
4
Universitätsklinik
Dresden, Germany