Urokinase Therapy in Diabetic Foot Syndrome

• Sponsor: medac GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00537498
• Collaborator: (none)
• Enrollment: 77
• Location: 1
• Arm: 1
• Duration (Months): 58
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot; Arterial Occlusive Disease; Ischemia	Drug: Urokinase	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Urokinase Therapy for Treatment of Angiopathic or Angioneuropathic Diabetic Foot Syndrome
• Study Start Date: Feb 1, 2002
• Actual Study Completion Date: Dec 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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

Outcome Measures

Primary Outcome Measures

1. Number of patients being alive, having no major amputation and healed ulceration [12 months]

Secondary Outcome Measures

1. Each of overall survival, major amputation rate, survival free of major amputation rate, rate of ulcer healing, and safety [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00537498
• Other Study ID Numbers: MC-UK.2/AVK
• First Posted: Oct 1, 2007
• Last Update Posted: Mar 25, 2010
• Last Verified: Sep 1, 2007

• Keywords provided by , ,: urokinase, diabetes, wound healing, major amputation
• Additional relevant MeSH terms: Diabetic Foot; Arterial Occlusive Diseases; Ischemia

Study Results

No Results Posted as of Mar 25, 2010