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Clinical Trial to Evaluate the Efficacy and Safety of Sodium Bemiparin for Treatment of Diabetic Foot Ulcers

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: NCT00448903
Recruitment Status : Completed
First Posted : March 19, 2007
Last Update Posted : March 17, 2011
Sponsor:
Information provided by:
Rovi Pharmaceuticals Laboratories

Tracking Information
First Submitted Date  ICMJE March 15, 2007
First Posted Date  ICMJE March 19, 2007
Last Update Posted Date March 17, 2011
Study Start Date  ICMJE March 2007
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2009)
total healing with intact skin or a significant improvement defined as a reduction of ulcer area > or = 50% or one degree reduction on Wagner Classification. [ Time Frame: 90 day ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2007)
total healing with intact skin or a significant improvement defined as a reduction of ulcer area ³ 50% or one degree reduction on Wagner Classification.
Change History Complete list of historical versions of study NCT00448903 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2009)
incidence of major bleeding and the incidence of adverse events. [ Time Frame: 210 day ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2007)
incidence of major bleeding and the incidence of adverse events.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Evaluate the Efficacy and Safety of Sodium Bemiparin for Treatment of Diabetic Foot Ulcers
Official Title  ICMJE Multicentric, Randomized, Double-blind, Controlled Clinical Trial to Assess the Efficacy and Safety of Bemiparin Sodium as Treatment of Diabetic Foot Ulcers
Brief Summary Chronic foot ulcers are a common, severe and expensive complication in patients with diabetes and often causes lower-extremity amputation. The aim of this study is to evaluate the effect of bemiparin as treatment of diabetic foot ulcers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Foot Ulcer, Diabetic
Intervention  ICMJE
  • Drug: Bemiparin
    Bemiparin sodium
    Other Names:
    • RO-11
    • Hibor
    • Zibor
    • Ivor
    • Badyket
    • Ivorat
    • Ivormax
    • Entervit
  • Drug: Placebo
    Sodium Chloride 0,9%
    Other Names:
    • Sodium Chloride
    • physiological saline
Study Arms  ICMJE
  • Experimental: A
    Bemiparin
    Intervention: Drug: Bemiparin
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2010)
329
Original Enrollment  ICMJE
 (submitted: March 16, 2007)
274
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients over 18 years old who have given their informed consent to participate in the study.
  • Patients with type I or II Diabetes Mellitus (ADA Criteria).
  • Presence of chronic neuropathic inframalleolar diabetic foot ulcer (starting at least 2 months before), grade I or II on Wagner Classification, without significant improvement (reduction of ulcer area > or = 25%) within the past 15 days prior to inclusion.
  • Ulcer size equal or bigger than 0.64 cm2 using the following formula: [Major axis] x [Minor axis]
  • Ankle-brachial index (ABI) > or = 0,7

Exclusion Criteria:

  • Patients with clinical symptoms of limb-threatening or life-threatening infection
  • Presence of bone exposure at the bottom of the ulcer and/or bone palpation by catheter and/or presence of radiological signs of pathological fractures and/or bone sequesters
  • Ankle-brachial index (ABI) <0,7
  • Subjects with arterial calcification (ABI > 1,3) with negative tibial and foot pulse that for any cause the Toe/Arm index (T/A) cannot be measured by plethysmography (photoplethysmography or strain-gauge)
  • Subjects with arterial calcification (ABI > 1,3) with negative tibial and foot pulse and with T/A index < 0,55 measured by plethysmography (photoplethysmography or strain-gauge)
  • Patients with hematological disorders, organic lesions susceptible to bleeding (e.g. active peptic ulcer, stroke, aneurysms), severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure over 120 mmHg).
  • Patients with severe renal failure (creatinine clearance <30 ml/min) or hepatic insufficiency (AST and/or ALT values >5 times the normal value established by the reference ranges of the local hospital laboratory).
  • Patients with connective tissue disease
  • Acute bacterial endocarditis or slow endocarditis.
  • Patients with antithrombin deficit and C and S protein deficit.
  • Patients with HbA1C > 12%.
  • Women who are pregnant or breast-feeding, or with the possibility of becoming pregnant during the study.
  • Known hypersensitivity to LMWH, heparin or substances of porcine origin.
  • Patients with a history of heparin-induced thrombocytopenia.
  • Patients on treatment with anticoagulant therapy at inclusion time or in the past 15 days.
  • Patients on treatment with pentoxifiline at inclusion time or in the past 30 days.
  • Patients on treatment with systemic corticosteroid or immunosuppressive therapy at inclusion time or in the past 3 months.
  • Patients on treatment with beclapermin at inclusion time or in the past 15 days.
  • Patients that have suffered a revascularization or endovascular surgery two months prior to inclusion
  • Patients with a life expectancy less than 6 months.
  • Patients that cannot complete the scheduled follow-up visits or are not able to complete the study period.
  • Patients who are participating in another clinical trial or have done it in the past 30 days.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Croatia,   Poland,   Romania,   Russian Federation,   Serbia,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00448903
Other Study ID Numbers  ICMJE ROV-BEM-2006-01
2006-005201-60
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rovi Pharmaceuticals Laboratories, Medical Department
Study Sponsor  ICMJE Rovi Pharmaceuticals Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: JR March, MD Getafe Hospital, E-28905 Getafe (Madrid) Spain
Study Chair: J Marinel-lo, MD Mataró Hospital, E-08304 Mataro (Barcelona) Spain
Study Chair: R Gómez Medialdea, MD Virgen de la Victoria Hospital, E-29010 Malaga, Spain
PRS Account Rovi Pharmaceuticals Laboratories
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP