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

This study has been completed.
Sponsor:
Information provided by:
Rovi Pharmaceuticals Laboratories
ClinicalTrials.gov Identifier:
NCT00448903
First received: March 15, 2007
Last updated: March 16, 2011
Last verified: May 2010
  Purpose

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 Intervention Phase
Foot Ulcer, Diabetic
Drug: Bemiparin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Rovi Pharmaceuticals Laboratories:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of major bleeding and the incidence of adverse events. [ Time Frame: 210 day ] [ Designated as safety issue: Yes ]

Enrollment: 329
Study Start Date: March 2007
Study Completion Date: April 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Bemiparin
Drug: Bemiparin
Bemiparin sodium
Other Names:
  • RO-11
  • Hibor
  • Zibor
  • Ivor
  • Badyket
  • Ivorat
  • Ivormax
  • Entervit
Placebo Comparator: 2
Placebo
Drug: Placebo
Sodium Chloride 0,9%
Other Names:
  • Sodium Chloride
  • physiological saline

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448903

Locations
Croatia
CROATIA
Zagreb, Croatia
Poland
POLAND
Warsaw, Poland
Romania
ROMANIA
Timisoara, Romania
Russian Federation
RUSSIA
St. Petersburg, Russian Federation
Serbia
SERBIA
Belgrade, Serbia
Spain
SPAIN
Madrid, Spain
Sponsors and Collaborators
Rovi Pharmaceuticals Laboratories
Investigators
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
  More Information

No publications provided

Responsible Party: Rovi Pharmaceuticals Laboratories, Medical Department
ClinicalTrials.gov Identifier: NCT00448903     History of Changes
Other Study ID Numbers: ROV-BEM-2006-01, 2006-005201-60
Study First Received: March 15, 2007
Last Updated: March 16, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Rovi Pharmaceuticals Laboratories:
diabetic
foot
ulcer
bemiparin
neuropathy
neuroishemic
diabetes

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on August 28, 2014