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Urokinase Therapy in Patients With Diabetic Foot Syndrome

Information source: medac GmbH
ClinicalTrials.gov processed this data on August 23, 2015
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: Terminated

Sponsored by: medac GmbH

Official(s) and/or principal investigator(s):
Sebastian Schellong, MD, Principal Investigator, Affiliation: Krankenhaus Dresden-Friedrichstadt, Germany


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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Franziskus Krankenhaus, Berlin, Germany

Klinikum Dortmund Nord GmbH, Dortmund, Germany

Krankenhaus Dresden-Neustadt, Dresden, Germany

Universit├Ątsklinik, Dresden, Germany

Wei├čeritztal-Kliniken GmbH, Freital, Germany

Klinikum Karlsbad Langensteinbach, Karlsbad, Germany

Additional Information

Starting date: June 2008
Last updated: March 12, 2015

Page last updated: August 23, 2015

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