Urokinase Therapy in Diabetic Foot Syndrome - Tabular View

Tracking Information

First Received Date ^ICMJE

September 28, 2007

Last Updated Date

September 28, 2007

Start Date ^ICMJE

February 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Number of patients being alive, having no major amputation and healed ulceration [ Time Frame: 12 months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Each of overall survival, major amputation rate, survival free of major amputation rate, rate of ulcer healing, and safety [ Time Frame: 12 months ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Urokinase Therapy in Diabetic Foot Syndrome

Official Title ^ICMJE

Phase II Study of Urokinase Therapy for Treatment of Angiopathic or Angioneuropathic Diabetic Foot Syndrome

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Diabetic Foot
Arterial Occlusive Disease
Ischemia

Intervention ^ICMJE

Drug: Urokinase

Study Arms / Comparison Groups

Experimental: Interventional group

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00537498

Responsible Party

Study ID Numbers ^ICMJE

MC-UK.2/AVK

Study Sponsor ^ICMJE

medac GmbH

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Sebastian M. Schellong, Professor

Universitätsklinikum Carl Gustav Carus TU Dresden UniversitätsGefäßcentrum

Information Provided By

medac GmbH

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP