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
Summary
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 mortalityminor 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
debridement
- expected further hospitalization for at least 3 weeks (pressure relief and
antibiosis)
- 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
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