Urokinase Therapy in Diabetic Foot Syndrome

This study has been completed.
Sponsor:
Information provided by:
medac GmbH
ClinicalTrials.gov Identifier:
NCT00537498
First received: September 28, 2007
Last updated: March 24, 2010
Last verified: September 2007
  Purpose

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 Intervention Phase
Diabetic Foot
Arterial Occlusive Disease
Ischemia
Drug: Urokinase
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Urokinase Therapy for Treatment of Angiopathic or Angioneuropathic Diabetic Foot Syndrome

Resource links provided by NLM:


Further study details as provided by medac GmbH:

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

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

Enrollment: 77
Study Start Date: February 2002
Study Completion Date: December 2006
Arms Assigned Interventions
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


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00537498     History of Changes
Other Study ID Numbers: MC-UK.2/AVK
Study First Received: September 28, 2007
Last Updated: March 24, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on August 28, 2014