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

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ClinicalTrials.gov Identifier: NCT01638585
Recruitment Status : Terminated (recruition number was not reached)
First Posted : July 11, 2012
Last Update Posted : April 7, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Critical Limb Ischemia Drug: urokinase Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patients With Diabetic Foot Syndrome and Critical Limb Ischemia - a Randomized Clinical Trial With Urokinase
Study Start Date : June 2011
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Urokinase
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
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


Outcome Measures

Primary Outcome Measures :
  1. Duration of survival without major amputation in urokinase group compared to group with standard therapy [ Time Frame: within the FU of 12 months ]

Secondary Outcome Measures :
  1. total mortality [ Time Frame: 12 months after randomization ]
  2. minor amputation [ Time Frame: 12 months after randomization ]
  3. Number of necessary revisions in case of minor amputation [ Time Frame: 12 months after randomization ]
  4. complete healing of targeted lesion [ Time Frame: within the FU of 12 months ]
  5. new lesions on previously affected leg [ Time Frame: within the FU of 12 months ]
  6. efficacy in dialysis patients [ Time Frame: within the FU of 12 months ]
  7. duration of hospital stay [ Time Frame: from baseline examination until first release (expected average of 2 weeks in general) ]
  8. re-hospitalization after dismissal following end of therapy with urokinase [ Time Frame: within the FU of 12 months ]
  9. 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.

  10. 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.

  11. incidence and type of bleeding events [ Time Frame: from randomization until day 33 ]
  12. incidence and type of other adverse events [ Time Frame: from baseline to end of 12 months FU ]
  13. new lesions on the contralateral leg [ Time Frame: within the FU of 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638585


Locations
Germany
Diabetes Klinik
Bad Mergentheim, Germany, 97980
Vivantes Klinikum im Friedrichshain
Berlin, Germany, 10249
Ev. KH Königin Elisabeth Herzberge
Berlin, Germany, 10365
Martin-Luther-Krankenhaus
Berlin, Germany, 14193
Klinikum Bielefeld gGmbH
Bielefeld, Germany, 33602
Stiftungsklinikum Mittelrhein
Boppard, Germany, 56154
Klinikum Chemnitz gGmbH
Chemnitz, Germany, 09113
Klinikum Dortmund gGmbH
Dortmund, Germany, 44145
Städtisches Krankenhaus DD-Neustadt
Dresden, Germany, 01129
Krankenhaus Dresden-Friedrichstadt
Dresden, Germany, 01307
Uniklinikum "Carl Gustav Carus" der TU Dresden
Dresden, Germany, 01307
Weißeritztal Kliniken GmbH
Freital, Germany, 01705
Asklepios Westklinikum
Hamburg, Germany, 22559
Universitätsklinikum Leipzig AöR
Leipzig, Germany, 04103
HELIOS Krankenhaus
Leisnig, Germany, 04703
Klinikum Westfalen/Klinikum am Park
Lünen, Germany, 44536
Klinikum Stuttgart, Bürgerhospital
Stuttgart, Germany, 70191
KH der Barmherzigen Brüder
Trier, Germany, 54292
Sponsors and Collaborators
GWT-TUD GmbH
Investigators
Principal Investigator: S. Schellong, Prof.Dr.med. Städt. KH Dresden-Friedrichstadt
More Information

Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT01638585     History of Changes
Other Study ID Numbers: August 2
2010-023426-20 ( EudraCT Number )
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Ischemia
Diabetic Foot
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies