Clinical trial NCT01599442: Register for Patients With Diabetic Foot Syndrome and Critical Limb Ischemia
Official title: Register for Patients With Diabetic Foot Syndrome and Critical Limb Ischemia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type 2 Diabetes Mellitus
Diabetic Foot
Critical Limb Ischemia
Lead sponsor: GWT-TUD GmbH
Sponsor class: OTHER
First posted: 2012-05-16
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatients from hospitals with a department specializing in the treatment of diabetic foot syndrome

Brief 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.

Eligibility 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).

Primary outcomes:
measure: duration of survival without major amputation
timeFrame: to be assessed after 12 months observation
Secondary outcomes:
measure: major amputation
timeFrame: after 12 months observation
measure: total mortality
timeFrame: after 12 months observation
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Krankenhaus Dresden-Friedrichstadt
state: Sachse
Study officials:
affiliation: Staedt. KH Dresden-Friedrichstadt
name: S. Schellong, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: