Urokinase Therapy in Patients With Diabetic Foot Syndrome
Information source: medac GmbH
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Foot; Arterial Occlusive Disease; Ischemia
Intervention: standard therapy (Procedure); Urokinase (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: medac GmbH Official(s) and/or principal investigator(s):
Sebastian Schellong, MD, Principal Investigator, Affiliation: Krankenhaus Dresden-Friedrichstadt, Germany
Overall contact:
Heiko Maacke, MD, Phone: +49 4103-8006-0, Ext: -570, Email: h.maacke@medac.de
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.
Clinical Details
Official title: Low Dose Urokinase Therapy in Patients With Diabetic Foot Syndrome and Critical Limb Ischemia Versus Conventional Standard Therapy
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Major amputation free survival
Secondary outcome: Total survival, major amputation rate, rate of complete ulcer healing, rate of adverse events
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Heiko Maacke, MD, Phone: +49 4103-8006-0, Ext: -570, Email: h.maacke@medac.de
Krankenhaus Dresden-Neustadt, Dresden, Germany; Recruiting
Andreas Kirsten, MD, Phone: +49 351-8562230, Email: andreas.kirsten@khdn.de
Andreas Kirsten, MD, Principal Investigator
Universitätsklinik, Dresden, Germany; Recruiting
Hannes Rietzsch, MD, Phone: +49 351-4584426
Hannes Rietzsch, MD, Principal Investigator
Franziskus Krankenhaus, Berlin, Germany; Recruiting
Jan Andre Schmidt-Lucke, MD, Phone: +49 30-2638-3601, Email: al-innere@franziskus-berlin.de
Jan Andre Schmnidt-Lucke, MD, Principal Investigator
Klinikum Karlsbad Langensteinbach, Karlsbad, Germany; Recruiting
Holger Lawall, MD, Phone: +49 7202-610, Email: holger.lawall@kkl.srh.de
Holger Lawall, MD, Principal Investigator
Klinikum Dortmund Nord GmbH, Dortmund, Germany; Recruiting
Johannes Hering, MD, Phone: +49 231-9530, Email: johannes.hering@klinikumdo.de
Johannes Hering, MD, Principal Investigator
Weißeritztal-Kliniken GmbH, Freital, Germany; Recruiting
Matthias Weck, MD, Phone: +49 351-6460, Email: mweck@t-online.de
Matthias Weck, MD, Principal Investigator
Additional Information
Starting date: June 2008
Ending date: May 2012
Last updated: January 14, 2009
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