Urokinase Therapy in Diabetic Foot Syndrome

NCT00537498 | Completed Phase 2

• 1 other identifier: MC-UK.2/AVK
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot; Arterial Occlusive Disease; Ischemia

Keywords

urokinase, diabetes, wound healing, major amputation

Outcome Measures

Primary Outcomes (1)

• Number of patients being alive, having no major amputation and healed ulceration

  12 months

Secondary Outcomes (1)

• Each of overall survival, major amputation rate, survival free of major amputation rate, rate of ulcer healing, and safety

  12 months

Study Arms (1)

1

EXPERIMENTAL

Interventional group

Drug: Urokinase

Interventions

Urokinase DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• angiopathic or angioneuropathic diabetic foot lesions
• critical limb ischemia
• no surgical or interventional treatment option

You may not qualify if:

• feasibility of vascular surgery or angioplasty
• prior treatment of the current ulceration with urokinase
• need for dialysis
• creatinine \> 180µmol/l
• proliferative retinopathy (not remediated)
• uncontrolled hypertension
• hemorrhagic diathesis
• gastrointestinal bleeding
• need for oral anticoagulation
• mental disorders
• pregnancy
• participation in another study

Sponsors & Collaborators

• medac GmbH: lead

Study Sites (1)

Universitätsklinikum Carl Gustav Carus UniversitätsGefäßcentrum

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Diabetic Foot; Arterial Occlusive Diseases; Ischemia; Diabetes Mellitus

Interventions

Urokinase-Type Plasminogen Activator

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Sebastian M. Schellong, Professor

  Universitätsklinikum Carl Gustav Carus TU Dresden UniversitätsGefäßcentrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 28, 2007
• First Posted: October 1, 2007
• Study Start: February 1, 2002
• Study Completion: December 1, 2006
• Last Updated: March 25, 2010

Record last verified: 2007-09

Locations

DE (1)