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

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ClinicalTrials.gov Identifier: NCT01599442
Recruitment Status : Terminated (recrution number was not reached)
First Posted : May 16, 2012
Last Update Posted : April 7, 2014
Sponsor:
Information provided by (Responsible Party):
GWT-TUD GmbH

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.


Condition or disease
Type 2 Diabetes Mellitus Diabetic Foot 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
Actual Enrollment : 123 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Register for Patients With Diabetic Foot Syndrome and Critical Limb Ischemia
Study Start Date : June 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. duration of survival without major amputation [ Time Frame: to be assessed after 12 months observation ]

Secondary Outcome Measures :
  1. major amputation [ Time Frame: after 12 months observation ]
  2. total mortality [ Time Frame: after 12 months observation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
outpatients from hospitals with a department specializing in the treatment of diabetic foot syndrome
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599442


Locations
Germany
Krankenhaus Dresden-Friedrichstadt
Dresden, Sachse, Germany, 01076
Sponsors and Collaborators
GWT-TUD GmbH
Investigators
Principal Investigator: S. Schellong, Prof.Dr.med. Staedt. KH Dresden-Friedrichstadt

Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT01599442     History of Changes
Other Study ID Numbers: August-1
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Ischemia
Diabetic Foot
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetic Neuropathies