Back to resultsUrokinase Therapy in Patients With Diabetic Foot Syndrome
Primary Purpose
Diabetic Foot, Arterial Occlusive Disease, Ischemia
Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
standard therapy
Urokinase
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot focused on measuring Diabetes, urokinase, ulcer healing, major amputation, survival
Eligibility 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
Sites / Locations
- Franziskus Krankenhaus
- Klinikum Dortmund Nord GmbH
- Krankenhaus Dresden-Neustadt
- Universitätsklinik
- Weißeritztal-Kliniken GmbH
- Klinikum Karlsbad Langensteinbach
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
A: Standard therapy
B: Urokinase
Arm Description
Outcomes
Primary Outcome Measures
Major amputation free survival
Secondary Outcome Measures
Total survival, major amputation rate, rate of complete ulcer healing, rate of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00823225
Brief Title
Urokinase Therapy in Patients With Diabetic Foot Syndrome
Official Title
Low Dose Urokinase Therapy in Patients With Diabetic Foot Syndrome and Critical Limb Ischemia Versus Conventional Standard Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment of study patients
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (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 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.
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.
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
Diabetes, urokinase, ulcer healing, major amputation, survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A: Standard therapy
Arm Type
Other
Arm Title
B: Urokinase
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
standard therapy
Intervention Description
wound debridement, moist wound dressing
Intervention Type
Drug
Intervention Name(s)
Urokinase
Intervention Description
Daily infusion up to 21 applications, dose dependent on fibrinogen level:
> 2,5g/l 1 000 000 IU, < 2,5g/l 500 000 IU
Primary Outcome Measure Information:
Title
Major amputation free survival
Time Frame
Within twelve months after randomisation
Secondary Outcome Measure Information:
Title
Total survival, major amputation rate, rate of complete ulcer healing, rate of adverse events
Time Frame
Within twelve month after randomisation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Schellong, MD
Organizational Affiliation
Krankenhaus Dresden-Friedrichstadt, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Franziskus Krankenhaus
City
Berlin
Country
Germany
Facility Name
Klinikum Dortmund Nord GmbH
City
Dortmund
Country
Germany
Facility Name
Krankenhaus Dresden-Neustadt
City
Dresden
Country
Germany
Facility Name
Universitätsklinik
City
Dresden
Country
Germany
Facility Name
Weißeritztal-Kliniken GmbH
City
Freital
Country
Germany
Facility Name
Klinikum Karlsbad Langensteinbach
City
Karlsbad
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Urokinase Therapy in Patients With Diabetic Foot Syndrome
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