Safety and Efficacy Study of Urokinase for the Treatment of Diabetic Foot Syndrome and Critical Limb Ischemia
NCT01638585 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2014-04-07
Summary
In this randomized clinical trial (RCT) the investigators are trying to find out whether a low-dose therapy with daily short infusions of urokinase using 10 to 21 doses over a maximum of 30 days is capable of prolonging the survival time without major amputation.
Conditions
- Diabetic Foot
- Critical Limb Ischemia
Interventions
- DRUG
-
urokinase
daily short infusions, i. e. i. v. application of 1.000.000 I.E. urokinase over 30 min. for at least 10 and up to 21 days during the 30 days after randomization
Sponsors & Collaborators
-
GWT-TUD GmbH
lead OTHER
Principal Investigators
-
S. Schellong, Prof.Dr.med. · Städt. KH Dresden-Friedrichstadt
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-06-30
- Primary Completion
- 2012-11-30
- Completion
- 2012-11-30
Countries
- Germany
Study Locations
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