Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
GWT-TUD GmbH

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Urokinase

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Show Show 18 study locations
Sponsors and Collaborators
GWT-TUD GmbH
Investigators
Layout table for investigator information
Principal Investigator: S. Schellong, Prof.Dr.med. Städt. KH Dresden-Friedrichstadt
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT01638585    
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:
Layout table for MeSH terms
Diabetic Foot
Chronic Limb-Threatening Ischemia
Ischemia
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
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Peripheral Vascular Diseases
Chronic Disease
Disease Attributes