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.
August-2 is a trial embedded in the August-1 registry study. All patients enrolled in August-2 are also part of August-1, but there will be patients who are documented in the register, but will not take part in August-2. The investigators want to find out to which extent the patients in the registry are representative to the overall population suffering from this condition and how the therapeutic success of other therapy regimes can be described.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
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
Diabetes Klinik
Bad Mergentheim, Germany
Vivantes Klinikum im Friedrichshain
Berlin, Germany
Duration of survival without major amputation in urokinase group compared to group with standard therapy
Time frame: within the FU of 12 months
total mortality
Time frame: 12 months after randomization
minor amputation
Time frame: 12 months after randomization
Number of necessary revisions in case of minor amputation
Time frame: 12 months after randomization
complete healing of targeted lesion
Time frame: within the FU of 12 months
new lesions on previously affected leg
Time frame: within the FU of 12 months
efficacy in dialysis patients
Time frame: within the FU of 12 months
duration of hospital stay
Time frame: from baseline examination until first release (expected average of 2 weeks in general)
re-hospitalization after dismissal following end of therapy with urokinase
Time frame: within the FU of 12 months
Necessity for parenteral therapy with vasoactive substances
During the follow-up it will be documented wether the administration of parenterally applied vasoactive substances or thrombocyte aggregation inhibitors was necessary.
Time frame: from baseline to end of 12 months FU
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Ev. KH Königin Elisabeth Herzberge
Berlin, Germany
Martin-Luther-Krankenhaus
Berlin, Germany
Klinikum Bielefeld gGmbH
Bielefeld, Germany
Stiftungsklinikum Mittelrhein
Boppard, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Germany
Klinikum Dortmund gGmbH
Dortmund, Germany
Städtisches Krankenhaus DD-Neustadt
Dresden, Germany
Krankenhaus Dresden-Friedrichstadt
Dresden, Germany
...and 8 more locations
cardiovascular events
Any major cardiovascular events during the follow-up period. Duration, severity, outcome and causal relationship with urokinase therapy will be documented.
Time frame: from baseline to end of 12 months FU
incidence and type of bleeding events
Time frame: from randomization until day 33
incidence and type of other adverse events
Time frame: from baseline to end of 12 months FU
new lesions on the contralateral leg
Time frame: within the FU of 12 months