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

GWT-TUD GmbH18 sites in 1 country34 target enrollmentJune 2011

ConditionsDiabetic Foot Critical Limb Ischemia

Interventionsurokinase

Drugsurokinase

Overview

Phase: Phase 3
Intervention: urokinase
Conditions: Diabetic Foot
Sponsor: GWT-TUD GmbH
Enrollment: 34
Locations: 18
Primary Endpoint: Duration of survival without major amputation in urokinase group compared to group with standard therapy
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

November 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GWT-TUD GmbH

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

urokinase

patients receiving urokinase short infusions in addition to standard therapy

Intervention: urokinase

Outcomes

Primary Outcomes

Duration of survival without major amputation in urokinase group compared to group with standard therapy

Time Frame: within the FU of 12 months

Secondary Outcomes

total mortality(12 months after randomization)
minor amputation(12 months after randomization)
Number of necessary revisions in case of minor amputation(12 months after randomization)
complete healing of targeted lesion(within the FU of 12 months)
new lesions on previously affected leg(within the FU of 12 months)
efficacy in dialysis patients(within the FU of 12 months)
duration of hospital stay(from baseline examination until first release (expected average of 2 weeks in general))
re-hospitalization after dismissal following end of therapy with urokinase(within the FU of 12 months)
Necessity for parenteral therapy with vasoactive substances(from baseline to end of 12 months FU)
cardiovascular events(from baseline to end of 12 months FU)
incidence and type of bleeding events(from randomization until day 33)
incidence and type of other adverse events(from baseline to end of 12 months FU)
new lesions on the contralateral leg(within the FU of 12 months)