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Safety and Efficacy Study of Urokinase for the Treatment of Diabetic Foot Syndrome and Critical Limb Ischemia (August2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01638585
Recruitment Status : Terminated (recruition number was not reached)
First Posted : July 11, 2012
Last Update Posted : April 7, 2014
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE May 14, 2012
First Posted Date  ICMJE July 11, 2012
Last Update Posted Date April 7, 2014
Study Start Date  ICMJE June 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2012)
Duration of survival without major amputation in urokinase group compared to group with standard therapy [ Time Frame: within the FU of 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2012)
  • total mortality [ Time Frame: 12 months after randomization ]
  • minor amputation [ Time Frame: 12 months after randomization ]
  • Number of necessary revisions in case of minor amputation [ Time Frame: 12 months after randomization ]
  • complete healing of targeted lesion [ Time Frame: within the FU of 12 months ]
  • new lesions on previously affected leg [ Time Frame: within the FU of 12 months ]
  • efficacy in dialysis patients [ Time Frame: within the FU of 12 months ]
  • duration of hospital stay [ Time Frame: from baseline examination until first release (expected average of 2 weeks in general) ]
  • re-hospitalization after dismissal following end of therapy with urokinase [ Time Frame: within the FU of 12 months ]
  • Necessity for parenteral therapy with vasoactive substances [ Time Frame: from baseline to end of 12 months FU ]
    During the follow-up it will be documented wether the administration of parenterally applied vasoactive substances or thrombocyte aggregation inhibitors was necessary.
  • cardiovascular events [ Time Frame: from baseline to end of 12 months FU ]
    Any major cardiovascular events during the follow-up period. Duration, severity, outcome and causal relationship with urokinase therapy will be documented.
  • incidence and type of bleeding events [ Time Frame: from randomization until day 33 ]
  • incidence and type of other adverse events [ Time Frame: from baseline to end of 12 months FU ]
  • new lesions on the contralateral leg [ Time Frame: within the FU of 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Urokinase for the Treatment of Diabetic Foot Syndrome and Critical Limb Ischemia
Official Title  ICMJE Patients With Diabetic Foot Syndrome and Critical Limb Ischemia - a Randomized Clinical Trial With Urokinase
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetic Foot
  • Critical Limb Ischemia
Intervention  ICMJE Drug: urokinase
daily short infusions, i. e. i. v. application of 1.000.000 I.E. urokinase over 30 min. for at least 10 and up to 21 days during the 30 days after randomization
Other Name: Urokinase HS medac
Study Arms  ICMJE
  • No Intervention: standard therapy
    patients receiving standard therapy for diabetic foot syndrome with critical limb ischemia, i. e. structured therapy of lesions with antibiosis, pressure relief and therapy of risk factors according to the relevant guidelines.
  • Active Comparator: urokinase
    patients receiving urokinase short infusions in addition to standard therapy
    Intervention: Drug: urokinase
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 4, 2014)
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2012)
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01638585
Other Study ID Numbers  ICMJE August 2
2010-023426-20 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party GWT-TUD GmbH
Original Responsible Party Same as current
Current Study Sponsor  ICMJE GWT-TUD GmbH
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: S. Schellong, Prof.Dr.med. Städt. KH Dresden-Friedrichstadt
PRS Account GWT-TUD GmbH
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP