Urokinase Therapy in Patients With Diabetic Foot Syndrome

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00823225

Enrollment

Registered

2009-01-15

Start date

2008-06-30

Completion date

2009-06-30

Last updated

2015-03-13

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

Diabetes, urokinase, ulcer healing, major amputation, survival

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.

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.

Interventions

PROCEDUREstandard therapy

wound debridement, moist wound dressing

DRUGUrokinase

Daily infusion up to 21 applications, dose dependent on fibrinogen level: \> 2,5g/l 1 000 000 IU, \< 2,5g/l 500 000 IU

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Major amputation free survival	Within twelve months after randomisation

Secondary

Measure	Time frame
Total survival, major amputation rate, rate of complete ulcer healing, rate of adverse events	Within twelve month after randomisation

Countries

Germany

Outcome results

None listed

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