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

Sponsor
GWT-TUD GmbH (Other)
Overall Status
Terminated
CT.gov ID
NCT01638585
Collaborator
(none)
34
Enrollment
18
Locations
2
Arms
17.1
Duration (Months)
1.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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
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
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 :
Jun 1, 2011
Actual Primary Completion Date :
Nov 1, 2012
Actual Study Completion Date :
Nov 1, 2012

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 Names:
  • Urokinase HS medac

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Duration of survival without major amputation in urokinase group compared to group with standard therapy [within the FU of 12 months]

    Secondary Outcome Measures

    1. total mortality [12 months after randomization]

    2. minor amputation [12 months after randomization]

    3. Number of necessary revisions in case of minor amputation [12 months after randomization]

    4. complete healing of targeted lesion [within the FU of 12 months]

    5. new lesions on previously affected leg [within the FU of 12 months]

    6. efficacy in dialysis patients [within the FU of 12 months]

    7. duration of hospital stay [from baseline examination until first release (expected average of 2 weeks in general)]

    8. re-hospitalization after dismissal following end of therapy with urokinase [within the FU of 12 months]

    9. Necessity for parenteral therapy with vasoactive substances [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 [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 [from randomization until day 33]

    12. incidence and type of other adverse events [from baseline to end of 12 months FU]

    13. new lesions on the contralateral leg [within the FU of 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Diabetes Klinik Bad Mergentheim Germany 97980
    2 Vivantes Klinikum im Friedrichshain Berlin Germany 10249
    3 Ev. KH Königin Elisabeth Herzberge Berlin Germany 10365
    4 Martin-Luther-Krankenhaus Berlin Germany 14193
    5 Klinikum Bielefeld gGmbH Bielefeld Germany 33602
    6 Stiftungsklinikum Mittelrhein Boppard Germany 56154
    7 Klinikum Chemnitz gGmbH Chemnitz Germany 09113
    8 Klinikum Dortmund gGmbH Dortmund Germany 44145
    9 Städtisches Krankenhaus DD-Neustadt Dresden Germany 01129
    10 Krankenhaus Dresden-Friedrichstadt Dresden Germany 01307
    11 Uniklinikum "Carl Gustav Carus" der TU Dresden Dresden Germany 01307
    12 Weißeritztal Kliniken GmbH Freital Germany 01705
    13 Asklepios Westklinikum Hamburg Germany 22559
    14 Universitätsklinikum Leipzig AöR Leipzig Germany 04103
    15 HELIOS Krankenhaus Leisnig Germany 04703
    16 Klinikum Westfalen/Klinikum am Park Lünen Germany 44536
    17 Klinikum Stuttgart, Bürgerhospital Stuttgart Germany 70191
    18 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GWT-TUD GmbH
    ClinicalTrials.gov Identifier:
    NCT01638585
    Other Study ID Numbers:
    • August 2
    • 2010-023426-20
    First Posted:
    Jul 11, 2012
    Last Update Posted:
    Apr 7, 2014
    Last Verified:
    Apr 1, 2014
    Additional relevant MeSH terms:
    Diabetic Foot
    Ischemia

    Study Results

    No Results Posted as of Apr 7, 2014