Urokinase Therapy in Patients With Diabetic Foot Syndrome

This study has been terminated.
(Insufficient recruitment of study patients)
Sponsor:
Information provided by:
medac GmbH
ClinicalTrials.gov Identifier:
NCT00823225
First received: January 14, 2009
Last updated: June 8, 2009
Last verified: June 2009
  Purpose

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 Intervention Phase
Diabetic Foot
Arterial Occlusive Disease
Ischemia
Procedure: standard therapy
Drug: Urokinase
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by medac GmbH:

Primary Outcome Measures:
  • Major amputation free survival [ Time Frame: Within twelve months after randomisation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Total survival, major amputation rate, rate of complete ulcer healing, rate of adverse events [ Time Frame: Within twelve month after randomisation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 130
Study Start Date: June 2008
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00823225

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

No publications provided

Responsible Party: Prof.Dr.med. S. Schellong, Städtisches Krankenhaus Dresden-Friedrichstadt, Friedrichstr. 41, 01067 Dresden, Germany
ClinicalTrials.gov Identifier: NCT00823225     History of Changes
Other Study ID Numbers: MC-UK.3/AVK, EudraCT number 2007-005916-15
Study First Received: January 14, 2009
Last Updated: June 8, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by medac GmbH:
Diabetes
urokinase
ulcer healing
major amputation
survival

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

ClinicalTrials.gov processed this record on September 18, 2014