Urokinase Therapy in Diabetic Foot Syndrome

Phase II Study of Urokinase Therapy for Treatment of Angiopathic or Angioneuropathic Diabetic Foot Syndrome

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00537498

Enrollment

Registered

2007-10-01

Start date

2002-02-28

Completion date

2006-12-31

Last updated

2010-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot, Arterial Occlusive Disease, Ischemia

Keywords

urokinase, diabetes, wound healing, major amputation

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.

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.

Interventions

DRUGUrokinase

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of patients being alive, having no major amputation and healed ulceration	12 months

Secondary

Measure	Time frame
Each of overall survival, major amputation rate, survival free of major amputation rate, rate of ulcer healing, and safety	12 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026