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

This study is currently recruiting participants.
Verified by Rovi Pharmaceuticals Laboratories, April 2008

Sponsored by: Rovi Pharmaceuticals Laboratories
Information provided by: Rovi Pharmaceuticals Laboratories
ClinicalTrials.gov Identifier: NCT00448903
  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 III

MedlinePlus related topics:   Diabetic Foot    Foot Health   

Drug Information available for:   Sodium chloride    Chlorides   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Multicentric, Randomized, Controlled, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Sodium Bemiparin for Treating Ulcers in Diabetic Foot

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. [ Designated as safety issue: No ]

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

Estimated Enrollment:   274
Study Start Date:   March 2007
Estimated Study Completion Date:   April 2009
Estimated Primary Completion Date:   October 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
Bemiparin
Drug: Bemiparin
Bemiparin sodium
2: Placebo Comparator
Placebo
Drug: Placebo
Sodium Chloride 0,9%

  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).
  • Inframaleolar neuropathic diabetic foot ulcer, grade I or II on Wagner Classification, without significant improvement (reduction of ulcer area > or = 25%) within the past 15 days.
  • 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 > 10%.
  • 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

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

Contacts
Contact: Rovi Medical Department     00 34 91 675 62 36     departamento.medico@rovi.es    

Locations
Romania
ROMANIA     Recruiting
      Timisoara, Romania
      Contact: Rovi Medical Department     00 34 91 375 62 30     departamento.medico@rovi.es    
Spain
Rovi     Recruiting
      Madrid, Spain, 28037
      Contact: Rovi medical department     00 34 91 375 62 36     departamento.medico@rovi.es    

Sponsors and Collaborators
Rovi Pharmaceuticals Laboratories

Investigators
Principal Investigator:     JR March, MD     Getafe Hospital    
Principal Investigator:     J Marinel-lo, MD     Mataró Hospital    
Principal Investigator:     R Gómez Medialdea, MD     VIrgen de las Nieves Hospital    
  More Information


Responsible Party:   Medical Department ( Rovi Pharmaceuticals Laboratories )
Study ID Numbers:   ROV-BEM-2006-01
First Received:   March 15, 2007
Last Updated:   May 5, 2008
ClinicalTrials.gov Identifier:   NCT00448903
Health Authority:   Spain: Spanish Agency of Medicines

Keywords provided by Rovi Pharmaceuticals Laboratories:
ulcers in diabetic foot  

Study placed in the following topic categories:
Foot Ulcer
Skin Diseases
Diabetic Neuropathies
Ulcer
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Foot Diseases
Diabetic Angiopathies
Endocrinopathy
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 31, 2008




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