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Diabetic FootPhase 3August2NCT01638585

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

A Phase 3 study testing urokinase in people with Diabetic Foot and Critical Limb Ischemia, run by GWT-TUD GmbH at 18 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Foot, Critical Limb Ischemia
What is being tested?
urokinase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
18 sitesGermany
Study dates
Jun 2011to Nov 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Germany18 sites

  • Diabetes Klinik

    Bad Mergentheim, 97980

  • Vivantes Klinikum im Friedrichshain

    Berlin, 10249

  • Ev. KH Königin Elisabeth Herzberge

    Berlin, 10365

  • Martin-Luther-Krankenhaus

    Berlin, 14193

  • Klinikum Bielefeld gGmbH

    Bielefeld, 33602

  • Stiftungsklinikum Mittelrhein

    Boppard, 56154

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09113

  • Klinikum Dortmund gGmbH

    Dortmund, 44145

  • Städtisches Krankenhaus DD-Neustadt

    Dresden, 01129

  • Krankenhaus Dresden-Friedrichstadt

    Dresden, 01307

  • Uniklinikum "Carl Gustav Carus" der TU Dresden

    Dresden, 01307

  • Weißeritztal Kliniken GmbH

    Freital, 01705

  • Asklepios Westklinikum

    Hamburg, 22559

  • Universitätsklinikum Leipzig AöR

    Leipzig, 04103

  • HELIOS Krankenhaus

    Leisnig, 04703

  • Klinikum Westfalen/Klinikum am Park

    Lünen, 44536

  • Klinikum Stuttgart, Bürgerhospital

    Stuttgart, 70191

  • KH der Barmherzigen Brüder

    Trier, 54292

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
urokinase
Medical subject headings
Diabetic Foot, Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • urokinaseDrug

    Also called Urokinase HS medac

    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

Study groups in NCT01638585
Study groupRoleWhat they receive
standard therapyNo interventionpatients 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.
urokinaseActive comparatorpatients receiving urokinase short infusions in addition to standard therapy
Receives: Drug: urokinase

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of survival without major amputation in urokinase group compared to group with standard therapy

    Measured: within the FU of 12 months

Secondary outcomes (13)

  1. total mortality

    Measured: 12 months after randomization

  2. minor amputation

    Measured: 12 months after randomization

  3. Number of necessary revisions in case of minor amputation

    Measured: 12 months after randomization

  4. complete healing of targeted lesion

    Measured: within the FU of 12 months

  5. new lesions on previously affected leg

    Measured: within the FU of 12 months

  6. efficacy in dialysis patients

    Measured: within the FU of 12 months

  7. duration of hospital stay

    Measured: from baseline examination until first release (expected average of 2 weeks in general)

  8. re-hospitalization after dismissal following end of therapy with urokinase

    Measured: within the FU of 12 months

  9. Necessity for parenteral therapy with vasoactive substances

    During the follow-up it will be documented wether the administration of parenterally applied vasoactive substances or thrombocyte aggregation inhibitors was necessary.

    Measured: from baseline to end of 12 months FU

  10. cardiovascular events

    Any major cardiovascular events during the follow-up period. Duration, severity, outcome and causal relationship with urokinase therapy will be documented.

    Measured: from baseline to end of 12 months FU

  11. incidence and type of bleeding events

    Measured: from randomization until day 33

  12. incidence and type of other adverse events

    Measured: from baseline to end of 12 months FU

  13. new lesions on the contralateral leg

    Measured: within the FU of 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2012 (estimated)
  2. Study startJun 2011
  3. Primary completionNov 2012
  4. Study completionNov 2012

Why it stopped: recruition number was not reached

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01638585
Sponsor's protocol ID
August 2
Other IDs
2010-023426-20
Acronym
August2
Status last verified
Apr 2014
First submitted
14 May 2012
Last updated
7 Apr 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing urokinase in people with Diabetic Foot and Critical Limb Ischemia, run by GWT-TUD GmbH at 18 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: recruition number was not reached). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of survival without major amputation in urokinase group compared to group with standard therapy (time frame: within the FU of 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01638585.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2014.

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