Register for Patients With Diabetic Foot Syndrome and Critical Limb Ischemia
Information source: GWT-TUD GmbH
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus; Diabetic Foot; Critical Limb Ischemia
Phase: N/A
Status: Terminated
Sponsored by: GWT-TUD GmbH Official(s) and/or principal investigator(s): S. Schellong, Prof.Dr.med., Principal Investigator, Affiliation: Staedt. KH Dresden-Friedrichstadt
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.
Clinical Details
Official title: Register for Patients With Diabetic Foot Syndrome and Critical Limb Ischemia
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: duration of survival without major amputation
Secondary outcome: major amputationtotal mortality
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- diabetic patients with dfs and critical limb ischemia
- age 18 and older
Exclusion Criteria:
- less than 1 year life expectancy
- prior major amputation
- planned major expectation
- prior treatment of the current episode of dfs with urokinase
- mechanical heart valve replacement
- cerebral event with changes in CT during the last three months
- non-remediated proliferating retinopathy
- uncontrolled hypertension (systolic > 180 mmHg, diastolic > 100 mmHg)
- hemorrhagic diathesis (spontaneous quick value < 50%, spontaneous ptt > 40 sec,
thrombocytes < 100 gpt/l)
- acute gastrointestinal bleeding or ulcers during the last 4 weeks
- prior reverse bypass operation
- concomitant participation in other clinical trials
- insufficient compliance
- premenopausal women not using a safe method of contraception (i. e. IUD, hormone
implants, hormone depot injection, combined pill (estrogens and gestagens), vaginal
ring or vasectomized partner).
Locations and Contacts
Krankenhaus Dresden-Friedrichstadt, Dresden, Sachse 01076, Germany
Additional Information
Starting date: June 2010
Last updated: April 4, 2014
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