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Safety and Efficacy Study of Urokinase for the Treatment of Diabetic Foot Syndrome and Critical Limb Ischemia

Information source: GWT-TUD GmbH
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Foot; Critical Limb Ischemia

Intervention: urokinase (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: GWT-TUD GmbH

Official(s) and/or principal investigator(s):
S. Schellong, Prof.Dr.med., Principal Investigator, Affiliation: Städt. KH Dresden-Friedrichstadt


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.

Clinical Details

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

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

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

Secondary outcome:

total mortality

minor amputation

Number of necessary revisions in case of minor amputation

complete healing of targeted lesion

new lesions on previously affected leg

efficacy in dialysis patients

duration of hospital stay

re-hospitalization after dismissal following end of therapy with urokinase

Necessity for parenteral therapy with vasoactive substances

cardiovascular events

incidence and type of bleeding events

incidence and type of other adverse events

new lesions on the contralateral leg

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.


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


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


- expected further hospitalization for at least 3 weeks (pressure relief and


- 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

- prior reverse bypass operation

- contraindications against therapy with urokinase acc. to the SMPc

- concurrent participation in another clinical trial

- insufficient compliance

- pregnancy

Locations and Contacts

Diabetes Klinik, Bad Mergentheim 97980, Germany

Ev. KH Königin Elisabeth Herzberge, Berlin 10365, Germany

Martin-Luther-Krankenhaus, Berlin 14193, Germany

Vivantes Klinikum im Friedrichshain, Berlin 10249, Germany

Klinikum Bielefeld gGmbH, Bielefeld 33602, Germany

Stiftungsklinikum Mittelrhein, Boppard 56154, Germany

Klinikum Chemnitz gGmbH, Chemnitz 09113, Germany

Klinikum Dortmund gGmbH, Dortmund 44145, Germany

Krankenhaus Dresden-Friedrichstadt, Dresden 01307, Germany

Städtisches Krankenhaus DD-Neustadt, Dresden 01129, Germany

Uniklinikum "Carl Gustav Carus" der TU Dresden, Dresden 01307, Germany

Weißeritztal Kliniken GmbH, Freital 01705, Germany

Asklepios Westklinikum, Hamburg 22559, Germany

Universitätsklinikum Leipzig AöR, Leipzig 04103, Germany

HELIOS Krankenhaus, Leisnig 04703, Germany

Klinikum Westfalen/Klinikum am Park, Lünen 44536, Germany

Klinikum Stuttgart, Bürgerhospital, Stuttgart 70191, Germany

KH der Barmherzigen Brüder, Trier 54292, Germany

Additional Information

Starting date: June 2011
Last updated: April 4, 2014

Page last updated: August 23, 2015

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