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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

Universit├Ątsklinik, 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

Wei├čeritztal-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

Page last updated: February 12, 2009

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