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Urokinase Therapy in Diabetic Foot Syndrome

Primary Purpose

Diabetic Foot, Arterial Occlusive Disease, Ischemia

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Urokinase
Sponsored by
medac GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring urokinase, diabetes, wound healing, major amputation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum Carl Gustav Carus UniversitätsGefäßcentrum

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Interventional group

Outcomes

Primary Outcome Measures

Number of patients being alive, having no major amputation and healed ulceration

Secondary Outcome Measures

Each of overall survival, major amputation rate, survival free of major amputation rate, rate of ulcer healing, and safety

Full Information

First Posted
September 28, 2007
Last Updated
March 24, 2010
Sponsor
medac GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00537498
Brief Title
Urokinase Therapy in Diabetic Foot Syndrome
Official Title
Phase II Study of Urokinase Therapy for Treatment of Angiopathic or Angioneuropathic Diabetic Foot Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
medac GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Arterial Occlusive Disease, Ischemia
Keywords
urokinase, diabetes, wound healing, major amputation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Interventional group
Intervention Type
Drug
Intervention Name(s)
Urokinase
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of patients being alive, having no major amputation and healed ulceration
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Each of overall survival, major amputation rate, survival free of major amputation rate, rate of ulcer healing, and safety
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian M. Schellong, Professor
Organizational Affiliation
Universitätsklinikum Carl Gustav Carus TU Dresden UniversitätsGefäßcentrum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Carl Gustav Carus UniversitätsGefäßcentrum
City
Dresden
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

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Urokinase Therapy in Diabetic Foot Syndrome

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