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Urokinase Therapy in Diabetic Foot Syndrome

NCT00537498 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2010-03-25

No results posted yet for this study

Summary

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.

Conditions

  • Diabetic Foot
  • Arterial Occlusive Disease
  • Ischemia

Interventions

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

Sponsors & Collaborators

  • medac GmbH

    lead INDUSTRY

Principal Investigators

  • Sebastian M. Schellong, Professor · Universitätsklinikum Carl Gustav Carus TU Dresden UniversitätsGefäßcentrum

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Completion
2006-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00537498 on ClinicalTrials.gov