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Urokinase Therapy in Diabetic Foot Syndrome

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ClinicalTrials.gov Identifier: NCT00537498
Recruitment Status : Completed
First Posted : October 1, 2007
Last Update Posted : March 25, 2010
Sponsor:
Information provided by:
medac GmbH

Brief Summary:
The purpose of this study is to evaluate whether a treatment with urokinase (500 000 or 1 000 000 IU) can lead to ulcer-healing, lower rate of major amputation, and prolonged survival in patients with diabetic foot syndrome.

Condition or disease Intervention/treatment Phase
Diabetic Foot Arterial Occlusive Disease Ischemia Drug: Urokinase Phase 2

Detailed Description:
Patients with diabetic foot ulceration and critical limb ischemia have a high risk of major amputation especially if limbs cannot be revascularized. Urokinase is effective in improving the microcirculation in critical limb ischemia by lowering fibrinogen and might improve outcomes. There are however no data on the efficacy and safety of urokinase treatment in terms of survival free of major amputation, ulcer healing and the rate of minor and major bleeding. Therefore this trial is conducted to investigate the effect of urokinase treatment on these parameters.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Urokinase Therapy for Treatment of Angiopathic or Angioneuropathic Diabetic Foot Syndrome
Study Start Date : February 2002
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Urokinase
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Interventional group
Drug: Urokinase

Daily intravenous application of urokinase over 30 minutes

Dosage:

If plasma fibrinogen is > 2,5g/l application of 1 000 000 IU Urokinase If plasma fibrinogen is < 2,5g/l application of 500 000 IU Urokinase If plasma fibrinogen is < 1,6g/l treatment must be stopped and continued after rising up to >2g/l




Primary Outcome Measures :
  1. Number of patients being alive, having no major amputation and healed ulceration [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Each of overall survival, major amputation rate, survival free of major amputation rate, rate of ulcer healing, and safety [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • angiopathic or angioneuropathic diabetic foot lesions
  • critical limb ischemia
  • no surgical or interventional treatment option

Exclusion Criteria:

  • feasibility of vascular surgery or angioplasty
  • prior treatment of the current ulceration with urokinase
  • need for dialysis
  • creatinine > 180µmol/l
  • any kind of cerebral event less than three months before inclusion into the study
  • proliferative retinopathy (not remediated)
  • uncontrolled hypertension
  • hemorrhagic diathesis
  • gastrointestinal bleeding
  • need for oral anticoagulation
  • mental disorders
  • pregnancy
  • participation in another study

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): NCT00537498


Locations
Germany
Universitätsklinikum Carl Gustav Carus UniversitätsGefäßcentrum
Dresden, Germany, 01307
Sponsors and Collaborators
medac GmbH
Investigators
Principal Investigator: Sebastian M. Schellong, Professor Universitätsklinikum Carl Gustav Carus TU Dresden UniversitätsGefäßcentrum

ClinicalTrials.gov Identifier: NCT00537498     History of Changes
Other Study ID Numbers: MC-UK.2/AVK
First Posted: October 1, 2007    Key Record Dates
Last Update Posted: March 25, 2010
Last Verified: September 2007

Keywords provided by medac GmbH:
urokinase, diabetes, wound healing, major amputation

Additional relevant MeSH terms:
Ischemia
Diabetic Foot
Arterial Occlusive Diseases
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies