Safety and Efficacy Study of Urokinase for the Treatment of Diabetic Foot Syndrome and Critical Limb Ischemia

• Status: Terminated
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

In this randomized clinical trial (RCT) the investigators are trying to find out whether a low-dose therapy with daily short infusions of urokinase using 10 to 21 doses over a maximum of 30 days is capable of prolonging the survival time without major amputation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GWT-TUD GmbH

Criteria

Inclusion Criteria:

• age 18 years or older

• angiopathic or angioneuropathic critical limb ischemia (at least Wagner-Armstrong stadium II)

• participation in the August-1 Register

• revascularization not possible or residual ischemia after revascularization

• persisting ulcerations despite antibiosis, adjustment of blood glucose levels and debridement

• expected further hospitalization for at least 3 weeks (pressure relief and antibiosis)

• fibrinogen >= 4g/l

• signed informed consent

Exclusion Criteria:

• life expectancy < 1 year

• prior major amputation

• planned major amputation

• prior therapy of the current episode of diabetic foot syndrome with urokinase (except in cases of revascularization when the duration between the intervention and randomization must not exceed 7 days)

• mechanical heart valve substitute

• cerebral event with CT-detectable changes in the last 3 months

• non-remediated proliferation retinopathy

• uncontrolled hypertension (systolic >180 mmg, diastolic >100 mmHg)

• hemorrhagic diathesis (spontaneous quick < 50%, spontaneous PTT > 40 s, thrombocytes < 100 Gpt/l)

• gastrointestinal bleeding or ulcers in the last 4 weeks

• prior reverse bypass operation

• contraindications against therapy with urokinase acc. to the SMPc

• concurrent participation in another clinical trial

• insufficient compliance

• pregnancy