Urokinase Therapy in Patients With Diabetic Foot Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00823225
Recruitment Status : Terminated (Insufficient recruitment of study patients)
First Posted : January 15, 2009
Last Update Posted : March 13, 2015
Information provided by:
medac GmbH

Brief Summary:
The purpose of this study is to determine whether the additional therapy with low dose urokinase is more effective than only a conventional standard therapy concerning ulcer-healing, rate of major amputation and survival.

Condition or disease Intervention/treatment Phase
Diabetic Foot Arterial Occlusive Disease Ischemia Procedure: standard therapy Drug: Urokinase Phase 3

Detailed Description:
Patients with diabetic foot ulceration and critical limb ischemia have a high risk of major amputation, especially if limbs can not be revascularized. Urokinase is effective in critical limb ischemia by lowering fibrinogen and might improve outcomes. The effect and safety of urokinase treatment was investigated in a phase II clinical trial. Based on the results this trial was planned to investigate the effect and safety of an additional therapy with urokinase versus a single conventional therapy.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low Dose Urokinase Therapy in Patients With Diabetic Foot Syndrome and Critical Limb Ischemia Versus Conventional Standard Therapy
Study Start Date : June 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
A: Standard therapy Procedure: standard therapy
wound debridement, moist wound dressing
Experimental: B: Urokinase Drug: Urokinase

Daily infusion up to 21 applications, dose dependent on fibrinogen level:

> 2,5g/l 1 000 000 IU, < 2,5g/l 500 000 IU

Primary Outcome Measures :
  1. Major amputation free survival [ Time Frame: Within twelve months after randomisation ]

Secondary Outcome Measures :
  1. Total survival, major amputation rate, rate of complete ulcer healing, rate of adverse events [ Time Frame: Within twelve month after randomisation ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diabetic patients with angiopathic or angioneuropathic diabetic foot syndrome and criticial limb ischemia
  • No surgical or interventional treatment option
  • No healing tendency of ulcerations despite of antibiosis and wound debridement after two-week treatment
  • Fibrinogen > 4.0 g/l
  • No previous major amputation

Exclusion Criteria:

  • Prior treatment of the current ulceration with urokinase
  • Need for dialysis and/or creatinine-clearance < 20ml/min
  • INR > 1,5 at screening
  • Any kind of cerebral event within 3 months prior inclusion
  • Proliferative retinopathy
  • Uncontrolled hypertension
  • Hemorraghic diathesis
  • Gastrointestinal bleeding
  • Pregnancy
  • No compliance and/or participation in another trial

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 identifier (NCT number): NCT00823225

Franziskus Krankenhaus
Berlin, Germany
Klinikum Dortmund Nord GmbH
Dortmund, Germany
Krankenhaus Dresden-Neustadt
Dresden, Germany
Dresden, Germany
Weißeritztal-Kliniken GmbH
Freital, Germany
Klinikum Karlsbad Langensteinbach
Karlsbad, Germany
Sponsors and Collaborators
medac GmbH
Principal Investigator: Sebastian Schellong, MD Krankenhaus Dresden-Friedrichstadt, Germany

Responsible Party: S. Schellong, Städtisches Krankenhaus Dresden-Friedrichstadt, Friedrichstr. 41, 01067 Dresden, Germany Identifier: NCT00823225     History of Changes
Other Study ID Numbers: MC-UK.3/AVK
EudraCT number 2007-005916-15
First Posted: January 15, 2009    Key Record Dates
Last Update Posted: March 13, 2015
Last Verified: March 2015

Keywords provided by medac GmbH:
ulcer healing
major amputation

Additional relevant MeSH terms:
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