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

April 4, 2014 updated by: GWT-TUD GmbH

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Urokinase HS medac

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Duration of survival without major amputation in urokinase group compared to group with standard therapy
Time Frame: within the FU of 12 months
within the FU of 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
total mortality
Time Frame: 12 months after randomization
12 months after randomization
minor amputation
Time Frame: 12 months after randomization
12 months after randomization
Number of necessary revisions in case of minor amputation
Time Frame: 12 months after randomization
12 months after randomization
complete healing of targeted lesion
Time Frame: within the FU of 12 months
within the FU of 12 months
new lesions on previously affected leg
Time Frame: within the FU of 12 months
within the FU of 12 months
efficacy in dialysis patients
Time Frame: within the FU of 12 months
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)
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
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.
from baseline to end of 12 months FU
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.
from baseline to end of 12 months FU
incidence and type of bleeding events
Time Frame: from randomization until day 33
from randomization until day 33
incidence and type of other adverse events
Time Frame: from baseline to end of 12 months FU
from baseline to end of 12 months FU
new lesions on the contralateral leg
Time Frame: within the FU of 12 months
within the FU of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GWT-TUD GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: S. Schellong, Prof.Dr.med., Städt. KH Dresden-Friedrichstadt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • August 2
  • 2010-023426-20 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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