Register for Patients With Diabetic Foot Syndrome and Critical Limb Ischemia (August-1)

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.

Study Overview

• Status: Terminated
• Conditions: Diabetic Foot; Type 2 Diabetes Mellitus; Critical Limb Ischemia

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.

• Study Type: Observational
• Enrollment (Actual): 123

Contacts and Locations

Study Locations

• Germany
  • Sachse
    • Dresden, Sachse, Germany, 01076
      • Krankenhaus Dresden-Friedrichstadt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

outpatients from hospitals with a department specializing in the treatment of diabetic foot syndrome

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
duration of survival without major amputation	to be assessed after 12 months observation

Secondary Outcome Measures

Outcome Measure	Time Frame
major amputation	after 12 months observation
total mortality	after 12 months observation

Collaborators and Investigators

• Sponsor: GWT-TUD GmbH
• Investigators: Principal Investigator: S. Schellong, Prof.Dr.med., Staedt. KH Dresden-Friedrichstadt

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: May 14, 2012
• First Submitted That Met QC Criteria: May 15, 2012
• First Posted (Estimate): May 16, 2012

Study Record Updates

• Last Update Posted (Estimate): April 7, 2014
• Last Update Submitted That Met QC Criteria: April 4, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetes Mellitus, Type 2; Diabetic Foot; Ischemia
• Other Study ID Numbers: August-1