Therapy with Urokinase in patients with diabetic foot, non-healing wounds and pain in comparison to the standard therapy.

• Conditions: Diabetic foot syndrome with critical limb ischemia; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2010-023426-20-DE
• Lead Sponsor: GWT-TUD GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-03
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients = 18 years with diabetes and angiopathic or angioneuropathic diabetic foot syndrome with critical limb ischemia (at least Wagner-Armstrong stage 2C)

Additional inclusion criteria:
•No revascularization possible or rest ischemia after revascularization (ALP with
collateral curve, to post-stenosis curve or dumb curve or ABI <0.9 or Doppler
trace with character of stenosis or missing, TcPO2 <30 mmHg)

•Persistent ulcerations in spite of anti-biosis, blood glucose adjustment and
wound debridement

•Expected further in-patient stay of at least 3 weeks (antibiotic therapy as well as
decompression)

•Fibrinogen = 4.0 g/ll

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 161

Exclusion Criteria

•prospective life expectancy <1 year
•former major amputation
•treatment strategy major amputation after interdisciplinary treatment team
•pre-treatment of the current episode of the diabetic foot syndrome with Urokinase (permitted in connection with the revascularization with the distance to the randomization then being minimally 7 days)

•mechanical heart valve replacement

•cerebral event with CT-alteration within the last 3 months

•non-cured, proliferative retinopathy

•uncontrollable hypertension (syst. RR > 80 mmHg, diast. RR >100 mmHg

•hemorrhagic diathesis (spontaneous-Quick <50%, spontaneous-PTT > 40 s,
platelets <100 Gpt/l)

•gastrointestinal bleeding or ulcers during the last 4 weeks

•reverse bypass operation

•existence of other contra-indications for a Urokinase therapy according to the
current specialized information

•concurrent participation in another clinical study

•lacking compliance

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Lengthening of survival free of major amputation by a low dose therapy with Urokinase as a daily short infusion with 10 to 21 doses over max. 30 days within the scope of a randomized, controlled study;Secondary Objective: •lengthening of survival free of major amputation one year after randomization<br>•major amputation<br>•overall mortality after 12 months<br>•minor amputation<br>•number of revision surgeries with minor amputations<br>•healing of the aim lesions (DFS)<br>•new lesions in the affected leg (index leg)<br>•new lesions in a previously not affected leg (not index leg)<br>•efficacy with dialysis patients<br><br>;Primary end point(s): Lengthening of the survival free of major amputation in the Urokinase group in contrast to the group treated with standard therapy. ;Timepoint(s) of evaluation of this end point: 12 months after randomization

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 12 months after randomization;Secondary end point(s): •lengthening of survival free of major amputation one year after randomization<br>•major amputation<br>•overall mortality after 12 months<br>•minor amputation<br>•number of revision surgeries with minor amputations<br>•healing of the aim lesions (DFS)<br>•new lesions in the affected leg (index leg)<br>•new lesions in a previously not affected leg (not index leg)<br>•efficacy with dialysis patients<br>