Urokinase Therapy in Patients With Diabetic Foot Syndrome

Diabetic Foot Clinical Trial

Official title:

Low Dose Urokinase Therapy in Patients With Diabetic Foot Syndrome and Critical Limb Ischemia Versus Conventional Standard Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00823225
• Other study ID #: MC-UK.3/AVK
• Secondary ID: EudraCT number 2
• Status: Terminated
• Phase: Phase 3
• First received: January 14, 2009
• Last updated: March 12, 2015
• Start date: June 2008
• Est. completion date: June 2009

Study information

• Verified date: March 2015
• Source: medac GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Disease
• Arterial Occlusive Diseases
• Diabetic Foot
• Ischemia

Intervention

Procedure:
• standard therapy
wound debridement, moist wound dressing

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

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
medac GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major amputation free survival		Within twelve months after randomisation	Yes
Secondary	Total survival, major amputation rate, rate of complete ulcer healing, rate of adverse events		Within twelve month after randomisation	Yes