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

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.

Condition or disease Intervention/treatment Phase
Foot Ulcer, Diabetic Drug: Bemiparin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 329 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicentric, Randomized, Double-blind, Controlled Clinical Trial to Assess the Efficacy and Safety of Bemiparin Sodium as Treatment of Diabetic Foot Ulcers
Study Start Date : March 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A
Drug: Bemiparin
Bemiparin sodium
Other Names:
  • RO-11
  • Hibor
  • Zibor
  • Ivor
  • Badyket
  • Ivorat
  • Ivormax
  • Entervit

Placebo Comparator: 2
Drug: Placebo
Sodium Chloride 0,9%
Other Names:
  • Sodium Chloride
  • physiological saline

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. incidence of major bleeding and the incidence of adverse events. [ Time Frame: 210 day ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00448903

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Zagreb, Croatia
Warsaw, Poland
Timisoara, Romania
Russian Federation
St. Petersburg, Russian Federation
Belgrade, Serbia
Madrid, Spain
Sponsors and Collaborators
Rovi Pharmaceuticals Laboratories
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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
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Responsible Party: Rovi Pharmaceuticals Laboratories, Medical Department Identifier: NCT00448903    
Other Study ID Numbers: ROV-BEM-2006-01
First Posted: March 19, 2007    Key Record Dates
Last Update Posted: March 17, 2011
Last Verified: May 2010
Keywords provided by Rovi Pharmaceuticals Laboratories:
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases