Urokinase Therapy in Patients With Diabetic Foot Syndrome - Full Text View

Sponsor:	medac GmbH
Information provided by:	medac GmbH
ClinicalTrials.gov Identifier:	NCT00823225

Purpose

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.

Condition	Intervention	Phase
Diabetic Foot Arterial Occlusive Disease Ischemia	Procedure: standard therapy Drug: Urokinase	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Low Dose Urokinase Therapy in Patients With Diabetic Foot Syndrome and Critical Limb Ischemia Versus Conventional Standard Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Foot Foot Health

Drug Information available for: Urokinase

U.S. FDA Resources

Further study details as provided by medac GmbH:

Primary Outcome Measures:

Major amputation free survival [ Time Frame: Within twelve months after randomisation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Total survival, major amputation rate, rate of complete ulcer healing, rate of adverse events [ Time Frame: Within twelve month after randomisation ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	130
Study Start Date:	June 2008
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Standard therapy	Procedure: standard therapy wound debridement, moist wound dressing
Experimental: B: Urokinase	Drug: Urokinase Daily infusion up to 21 applications, dose dependent on fibrinogen level: > 2,5g/l 1 000 000 IU, < 2,5g/l 500 000 IU

Detailed Description:

Patients with diabetic foot ulceration and critical limb ischemia have a high risk of major amputation, especially if limbs can not be revascularized. Urokinase is effective in critical limb ischemia by lowering fibrinogen and might improve outcomes. The effect and safety of urokinase treatment was investigated in a phase II clinical trial. Based on the results this trial was planned to investigate the effect and safety of an additional therapy with urokinase versus a single conventional therapy.

Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Prior treatment of the current ulceration with urokinase
Need for dialysis and/or creatinine-clearance < 20ml/min
INR > 1,5 at screening
Any kind of cerebral event within 3 months prior inclusion
Proliferative retinopathy
Uncontrolled hypertension
Hemorraghic diathesis
Gastrointestinal bleeding
Pregnancy
No compliance and/or participation in another trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823225

Locations

Germany
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

Sponsors and Collaborators

medac GmbH

Investigators

Principal Investigator:

Sebastian Schellong, MD

Krankenhaus Dresden-Friedrichstadt, Germany

More Information

No publications provided

Responsible Party:	Prof.Dr.med. S. Schellong, Städtisches Krankenhaus Dresden-Friedrichstadt, Friedrichstr. 41, 01067 Dresden, Germany
ClinicalTrials.gov Identifier:	NCT00823225 History of Changes
Other Study ID Numbers:	MC-UK.3/AVK, EudraCT number 2007-005916-15
Study First Received:	January 14, 2009
Last Updated:	June 8, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by medac GmbH:

Diabetes
urokinase
ulcer healing
major amputation
survival

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Ischemia
Diabetic Foot
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Diabetic Angiopathies
Foot Ulcer

Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on May 23, 2012