Register for Patients With Diabetic Foot Syndrome and Critical Limb Ischemia

Type 2 Diabetes Mellitus Clinical Trial

— August-1  

Official title:

Register for Patients With Diabetic Foot Syndrome and Critical Limb Ischemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01599442
• Other study ID #: August-1
• Status: Terminated
• Phase: N/A
• First received: May 14, 2012
• Last updated: April 4, 2014
• Start date: June 2010
• Est. completion date: July 2013

Study information

• Verified date: April 2014
• Source: GWT-TUD GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 123
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Diabetes Mellitus, Type 2
• Diabetic Foot
• Ischemia
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
Germany	Krankenhaus Dresden-Friedrichstadt	Dresden	Sachse

Sponsors (1)

Lead Sponsor	Collaborator
GWT-TUD GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of survival without major amputation		to be assessed after 12 months observation	No
Secondary	major amputation		after 12 months observation	No
Secondary	total mortality		after 12 months observation	No