Register for Patients With Diabetic Foot Syndrome and Critical Limb Ischemia (August-1)
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|ClinicalTrials.gov Identifier: NCT01599442|
Recruitment Status : Terminated (recrution number was not reached)
First Posted : May 16, 2012
Last Update Posted : April 7, 2014
Diabetic foot syndrome (DFS) is a disease caused by neurogenic (concerning the nervous system), vascular, mechanic and metabolic factors, which are further complicated by an impairment of the immune system and a corresponding increase in the risk for infections. Results from clinical trials about the efficacy of interventions aimed at reducing the number of patient-relevant end points are of limited comparability due to the heterogenity of patient characteristics. By their very nature, randomized clinical trials (RCT) can only focus on a limited section of the wide range of possible intervention regimes. In clinical practice, however, a number of patients with dfs will never have been part of a clinical trial. Furthermore, there are only very few contemporary registers for this indication from which conclusions with regard to the comparative merits of different therapeutic strategies may be drawn.
The register was conceived to find out to which extent RCT patients are representative for the overall patient collective with dfs and critical limb ischemia and to evaluate the therapeutic success of other treatment strategies. An RCT to assess the efficacy of urokinase versus placebo is imbedded in the register.
|Condition or disease|
|Type 2 Diabetes Mellitus Diabetic Foot Critical Limb Ischemia|
|Study Type :||Observational|
|Actual Enrollment :||123 participants|
|Official Title:||Register for Patients With Diabetic Foot Syndrome and Critical Limb Ischemia|
|Study Start Date :||June 2010|
|Primary Completion Date :||July 2013|
|Study Completion Date :||July 2013|
- duration of survival without major amputation [ Time Frame: to be assessed after 12 months observation ]
- major amputation [ Time Frame: after 12 months observation ]
- total mortality [ Time Frame: after 12 months observation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599442
|Dresden, Sachse, Germany, 01076|
|Principal Investigator:||S. Schellong, Prof.Dr.med.||Staedt. KH Dresden-Friedrichstadt|