Trials / Terminated
TerminatedNCT01599442
Register for Patients With Diabetic Foot Syndrome and Critical Limb Ischemia
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 123 (actual)
- Sponsor
- GWT-TUD GmbH · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Timeline
- Start date
- 2010-06-01
- Primary completion
- 2013-07-01
- Completion
- 2013-07-01
- First posted
- 2012-05-16
- Last updated
- 2014-04-07
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01599442. Inclusion in this directory is not an endorsement.