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Sponsored by: |
Rovi Pharmaceuticals Laboratories |
Information provided by: | Rovi Pharmaceuticals Laboratories |
ClinicalTrials.gov Identifier: | NCT00448903 |
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 |
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 |
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
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Drug: Bemiparin
Bemiparin sodium
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2: Placebo Comparator
Placebo
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Drug: Placebo
Sodium Chloride 0,9%
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rovi Medical Department | 00 34 91 675 62 36 | departamento.medico@rovi.es |
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 |
Rovi Pharmaceuticals Laboratories |
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 |
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 |
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