Type 2 Diabetes Mellitus Clinical Trial
Official title:
Register for Patients With Diabetic Foot Syndrome and Critical Limb Ischemia
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.
August-1 is a register 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. ;
Observational Model: Cohort, Time Perspective: Prospective
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