Register for Patients With Diabetic Foot Syndrome and Critical Limb Ischemia

NCT01599442 | Terminated

• 1 other identifier: August-1
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Diabetic Foot; Critical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• duration of survival without major amputation

  to be assessed after 12 months observation

Secondary Outcomes (2)

• major amputation

  after 12 months observation

• total mortality

  after 12 months observation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• diabetic patients with dfs and critical limb ischemia
• age 18 and older

You may not qualify if:

• 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).

Sponsors & Collaborators

• GWT-TUD GmbH: lead

Study Sites (1)

Krankenhaus Dresden-Friedrichstadt

Dresden, Sachse, 01076, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Foot; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies; Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• S. Schellong, Prof.Dr.med.

  Staedt. KH Dresden-Friedrichstadt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 16, 2012
• Study Start: June 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 7, 2014

Record last verified: 2014-04

Locations

DE (1)