Urokinase Therapy in Diabetic Foot Syndrome

March 24, 2010 updated by: medac GmbH

Phase II Study of Urokinase Therapy for Treatment of Angiopathic or Angioneuropathic Diabetic Foot Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

77

Phase

  • Phase 2

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
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus UniversitätsGefäßcentrum

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients being alive, having no major amputation and healed ulceration
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Each of overall survival, major amputation rate, survival free of major amputation rate, rate of ulcer healing, and safety
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

medac GmbH

Investigators

  • Principal Investigator: Sebastian M. Schellong, Professor, Universitätsklinikum Carl Gustav Carus TU Dresden UniversitätsGefäßcentrum

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

February 1, 2002

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 28, 2007

First Submitted That Met QC Criteria

September 28, 2007

First Posted (Estimate)

October 1, 2007

Study Record Updates

Last Update Posted (Estimate)

March 25, 2010

Last Update Submitted That Met QC Criteria

March 24, 2010

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC-UK.2/AVK

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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