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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023426-20 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard therapy | No Intervention | patients receiving standard therapy for diabetic foot syndrome with critical limb ischemia, i. e. structured therapy of lesions with antibiosis, pressure relief and therapy of risk factors according to the relevant guidelines. | |
| urokinase | Active Comparator | patients receiving urokinase short infusions in addition to standard therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| urokinase | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of survival without major amputation in urokinase group compared to group with standard therapy | within the FU of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| total mortality | 12 months after randomization | |
| minor amputation | 12 months after randomization | |
| Number of necessary revisions in case of minor amputation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| S. Schellong, Prof.Dr.med. | Städt. KH Dresden-Friedrichstadt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes Klinik | Bad Mergentheim | 97980 | Germany | |||
| Vivantes Klinikum im Friedrichshain |
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|
| 12 months after randomization |
| complete healing of targeted lesion | within the FU of 12 months |
| new lesions on previously affected leg | within the FU of 12 months |
| efficacy in dialysis patients | within the FU of 12 months |
| duration of hospital stay | from baseline examination until first release (expected average of 2 weeks in general) |
| re-hospitalization after dismissal following end of therapy with urokinase | 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. | from baseline to end of 12 months FU |
| cardiovascular events | Any major cardiovascular events during the follow-up period. Duration, severity, outcome and causal relationship with urokinase therapy will be documented. | from baseline to end of 12 months FU |
| incidence and type of bleeding events | from randomization until day 33 |
| incidence and type of other adverse events | from baseline to end of 12 months FU |
| new lesions on the contralateral leg | within the FU of 12 months |
| Berlin |
| 10249 |
| Germany |
| Ev. KH Königin Elisabeth Herzberge | Berlin | 10365 | Germany |
| Martin-Luther-Krankenhaus | Berlin | 14193 | Germany |
| Klinikum Bielefeld gGmbH | Bielefeld | 33602 | Germany |
| Stiftungsklinikum Mittelrhein | Boppard | 56154 | Germany |
| Klinikum Chemnitz gGmbH | Chemnitz | 09113 | Germany |
| Klinikum Dortmund gGmbH | Dortmund | 44145 | Germany |
| Städtisches Krankenhaus DD-Neustadt | Dresden | 01129 | Germany |
| Krankenhaus Dresden-Friedrichstadt | Dresden | 01307 | Germany |
| Uniklinikum "Carl Gustav Carus" der TU Dresden | Dresden | 01307 | Germany |
| Weißeritztal Kliniken GmbH | Freital | 01705 | Germany |
| Asklepios Westklinikum | Hamburg | 22559 | Germany |
| Universitätsklinikum Leipzig AöR | Leipzig | 04103 | Germany |
| HELIOS Krankenhaus | Leisnig | 04703 | Germany |
| Klinikum Westfalen/Klinikum am Park | Lünen | 44536 | Germany |
| Klinikum Stuttgart, Bürgerhospital | Stuttgart | 70191 | Germany |
| KH der Barmherzigen Brüder | Trier | 54292 | Germany |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
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| ID | Term |
|---|---|
| D014568 | Urokinase-Type Plasminogen Activator |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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