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

This study has been terminated.
(recruition number was not reached)
Sponsor:
Information provided by (Responsible Party):
GWT-TUD GmbH
ClinicalTrials.gov Identifier:
NCT01638585
First received: May 14, 2012
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Diabetic Foot
Critical Limb Ischemia
Drug: urokinase
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Patients With Diabetic Foot Syndrome and Critical Limb Ischemia - a Randomized Clinical Trial With Urokinase

Resource links provided by NLM:


Further study details as provided by GWT-TUD GmbH:

Primary Outcome Measures:
  • Duration of survival without major amputation in urokinase group compared to group with standard therapy [ Time Frame: within the FU of 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • total mortality [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
  • minor amputation [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
  • Number of necessary revisions in case of minor amputation [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
  • complete healing of targeted lesion [ Time Frame: within the FU of 12 months ] [ Designated as safety issue: No ]
  • new lesions on previously affected leg [ Time Frame: within the FU of 12 months ] [ Designated as safety issue: No ]
  • efficacy in dialysis patients [ Time Frame: within the FU of 12 months ] [ Designated as safety issue: No ]
  • duration of hospital stay [ Time Frame: from baseline examination until first release (expected average of 2 weeks in general) ] [ Designated as safety issue: No ]
  • re-hospitalization after dismissal following end of therapy with urokinase [ Time Frame: within the FU of 12 months ] [ Designated as safety issue: No ]
  • Necessity for parenteral therapy with vasoactive substances [ Time Frame: from baseline to end of 12 months FU ] [ Designated as safety issue: No ]
    During the follow-up it will be documented wether the administration of parenterally applied vasoactive substances or thrombocyte aggregation inhibitors was necessary.

  • cardiovascular events [ Time Frame: from baseline to end of 12 months FU ] [ Designated as safety issue: No ]
    Any major cardiovascular events during the follow-up period. Duration, severity, outcome and causal relationship with urokinase therapy will be documented.

  • incidence and type of bleeding events [ Time Frame: from randomization until day 33 ] [ Designated as safety issue: Yes ]
  • incidence and type of other adverse events [ Time Frame: from baseline to end of 12 months FU ] [ Designated as safety issue: Yes ]
  • new lesions on the contralateral leg [ Time Frame: within the FU of 12 months ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: June 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01638585

Locations
Germany
Diabetes Klinik
Bad Mergentheim, Germany, 97980
Ev. KH Königin Elisabeth Herzberge
Berlin, Germany, 10365
Vivantes Klinikum im Friedrichshain
Berlin, Germany, 10249
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
Krankenhaus Dresden-Friedrichstadt
Dresden, Germany, 01307
Uniklinikum "Carl Gustav Carus" der TU Dresden
Dresden, Germany, 01307
Städtisches Krankenhaus DD-Neustadt
Dresden, Germany, 01129
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

No publications provided

Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT01638585     History of Changes
Other Study ID Numbers: August 2, 2010-023426-20
Study First Received: May 14, 2012
Last Updated: April 4, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on April 17, 2014