Urokinase Therapy in Patients With Diabetic Foot Syndrome

Sponsor

medac GmbH (Industry)

Overall Status

Terminated

CT.gov ID

NCT00823225

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

0.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Arm

Intervention/Treatment

Other: 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

Outcome Measures

Primary Outcome Measures

Major amputation free survival [Within twelve months after randomisation]

Secondary Outcome Measures

Total survival, major amputation rate, rate of complete ulcer healing, rate of adverse events [Within twelve month after randomisation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	Franziskus Krankenhaus	Berlin	Germany
2	Klinikum Dortmund Nord GmbH	Dortmund	Germany
3	Krankenhaus Dresden-Neustadt	Dresden	Germany
4	Universitätsklinik	Dresden	Germany
5	Weißeritztal-Kliniken GmbH	Freital	Germany
6	Klinikum Karlsbad Langensteinbach	Karlsbad	Germany