Study Stopped
Insufficient recruitment of study patients
Urokinase Therapy in Patients With Diabetic Foot Syndrome
Low Dose Urokinase Therapy in Patients With Diabetic Foot Syndrome and Critical Limb Ischemia Versus Conventional Standard Therapy
2 other identifiers
interventional
5
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2008
Shorter than P25 for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 14, 2009
CompletedFirst Posted
Study publicly available on registry
January 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedMarch 13, 2015
March 1, 2015
1 year
January 14, 2009
March 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major amputation free survival
Within twelve months after randomisation
Secondary Outcomes (1)
Total survival, major amputation rate, rate of complete ulcer healing, rate of adverse events
Within twelve month after randomisation
Study Arms (2)
A: Standard therapy
OTHERB: Urokinase
EXPERIMENTALInterventions
Daily infusion up to 21 applications, dose dependent on fibrinogen level: \> 2,5g/l 1 000 000 IU, \< 2,5g/l 500 000 IU
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Prior treatment of the current ulceration with urokinase
- Need for dialysis and/or creatinine-clearance \< 20ml/min
- INR \> 1,5 at screening
- Proliferative retinopathy
- Uncontrolled hypertension
- Hemorraghic diathesis
- Gastrointestinal bleeding
- Pregnancy
- No compliance and/or participation in another trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- medac GmbHlead
Study Sites (6)
Franziskus Krankenhaus
Berlin, Germany
Klinikum Dortmund Nord GmbH
Dortmund, Germany
Krankenhaus Dresden-Neustadt
Dresden, Germany
Universitätsklinik
Dresden, Germany
Weißeritztal-Kliniken GmbH
Freital, Germany
Klinikum Karlsbad Langensteinbach
Karlsbad, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastian Schellong, MD
Krankenhaus Dresden-Friedrichstadt, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 14, 2009
First Posted
January 15, 2009
Study Start
June 1, 2008
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
March 13, 2015
Record last verified: 2015-03