Urokinase Therapy in Patients With Diabetic Foot Syndrome

March 12, 2015 updated by: medac GmbH

Low Dose Urokinase Therapy in Patients With Diabetic Foot Syndrome and Critical Limb Ischemia Versus Conventional Standard Therapy

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

5

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Franziskus Krankenhaus
      • Dortmund, Germany
        • Klinikum Dortmund Nord GmbH
      • Dresden, Germany
        • Krankenhaus Dresden-Neustadt
      • Dresden, Germany
        • Universitätsklinik
      • Freital, Germany
        • Weißeritztal-Kliniken GmbH
      • Karlsbad, Germany
        • Klinikum Karlsbad Langensteinbach

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major amputation free survival
Time Frame: Within twelve months after randomisation
Within twelve months after randomisation

Secondary Outcome Measures

Outcome Measure
Time Frame
Total survival, major amputation rate, rate of complete ulcer healing, rate of adverse events
Time Frame: Within twelve month after randomisation
Within twelve month after randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

medac GmbH

Investigators

  • Principal Investigator: Sebastian Schellong, MD, Krankenhaus Dresden-Friedrichstadt, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

January 14, 2009

First Submitted That Met QC Criteria

January 14, 2009

First Posted (Estimate)

January 15, 2009

Study Record Updates

Last Update Posted (Estimate)

March 13, 2015

Last Update Submitted That Met QC Criteria

March 12, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC-UK.3/AVK
  • EudraCT number 2007-005916-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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