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Urokinase Therapy in Diabetic Foot Syndrome

Information source: medac GmbH
ClinicalTrials.gov processed this data on August 23, 2015
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


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: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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
Last updated: March 24, 2010

Page last updated: August 23, 2015

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