Urokinase Therapy in Diabetic Foot Syndrome
Information source: medac GmbH
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Foot; Arterial Occlusive Disease; Ischemia
Intervention: Urokinase (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: medac GmbH Official(s) and/or principal investigator(s):
Sebastian M. Schellong, Professor, Principal Investigator, Affiliation: Universitätsklinikum Carl Gustav Carus TU Dresden UniversitätsGefäßcentrum
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.
Clinical Details
Official title: Phase II Study of Urokinase Therapy for Treatment of Angiopathic or Angioneuropathic Diabetic Foot Syndrome
Study design: Treatment, Open Label, Single Group Assignment, Efficacy Study
Primary outcome: Number of patients being alive, having no major amputation and healed ulceration
Secondary outcome: Each of overall survival, major amputation rate, survival free of major amputation rate, rate of ulcer healing, and safety
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Universitätsklinikum Carl Gustav Carus UniversitätsGefäßcentrum, Dresden 01307, Germany
Additional Information
Starting date: February 2002
Ending date: December 2006
Last updated: September 28, 2007
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