Urokinase Therapy in Diabetic Foot Syndrome - Full Text View

Sponsored by:	medac GmbH
Information provided by:	medac GmbH
ClinicalTrials.gov Identifier:	NCT00537498

Purpose

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.

Condition	Intervention	Phase
Diabetic Foot Arterial Occlusive Disease Ischemia	Drug: Urokinase	Phase II

MedlinePlus related topics: Diabetic Foot Foot Health

Drug Information available for: Urokinase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Phase II Study of Urokinase Therapy for Treatment of Angiopathic or Angioneuropathic Diabetic Foot Syndrome

Further study details as provided by medac GmbH:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	77
Study Start Date:	February 2002
Study Completion Date:	December 2006

Arms	Assigned Interventions
1: Experimental Interventional group	Drug: Urokinase Daily intravenous application of urokinase over 30 minutes Dosage: If plasma fibrinogen is > 2,5g/l application of 1 000 000 IU Urokinase If plasma fibrinogen is < 2,5g/l application of 500 000 IU Urokinase If plasma fibrinogen is < 1,6g/l treatment must be stopped and continued after rising up to >2g/l

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537498

Locations

Germany
Universitätsklinikum Carl Gustav Carus UniversitätsGefäßcentrum
Dresden, Germany, 01307

Sponsors and Collaborators

medac GmbH

Investigators

Principal Investigator:

Sebastian M. Schellong, Professor

Universitätsklinikum Carl Gustav Carus TU Dresden UniversitätsGefäßcentrum

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	MC-UK.2/AVK
Study First Received:	September 28, 2007
Last Updated:	September 28, 2007
ClinicalTrials.gov Identifier:	NCT00537498 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by medac GmbH:

urokinase, diabetes, wound healing, major amputation

Study placed in the following topic categories:

Arterial Occlusive Diseases
Foot Ulcer
Diabetic Neuropathies
Skin Diseases
Ulcer
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases

Ischemia
Diabetic Angiopathies
Endocrinopathy
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Foot Ulcer
Diabetic Neuropathies
Skin Diseases
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Ischemia

Diabetic Angiopathies
Pathologic Processes
Cardiovascular Diseases
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

ClinicalTrials.gov processed this record on May 06, 2009