NCT01638585

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

Patients With Diabetic Foot Syndrome and Critical Limb Ischemia - a Randomized Clinical Trial With Urokinase

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: GWT-TUD GmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

August-2 is a trial embedded in the August-1 registry study. All patients enrolled in August-2 are also part of August-1, but there will be patients who are documented in the register, but will not take part in August-2. The investigators want to find out to which extent the patients in the registry are representative to the overall population suffering from this condition and how the therapeutic success of other therapy regimes can be described.

Conditions

• Diabetic Foot
• Critical Limb Ischemia

Interventions

Type	Name	Description
DRUG	urokinase	daily short infusions, i. e. i. v. application of 1.000.000 I.E. urokinase over 30 min. for at least 10 and up to 21 days during the 30 days after randomization

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-07-11
• Last updated: 2014-04-07

Locations

18 sites across 1 country: Germany