Clinical Trial to Evaluate the Efficacy and Safety of Sodium Bemiparin for Treatment of Diabetic Foot Ulcers
This study has been completed.
Information provided by:
Rovi Pharmaceuticals Laboratories
First received: March 15, 2007
Last updated: March 16, 2011
Last verified: May 2010
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.
Foot Ulcer, Diabetic
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Multicentric, Randomized, Double-blind, Controlled Clinical Trial to Assess the Efficacy and Safety of Bemiparin Sodium as Treatment of Diabetic Foot Ulcers
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2009 (Final data collection date for primary outcome measure)
Placebo Comparator: 2
Sodium Chloride 0,9%
- Sodium Chloride
- physiological saline
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00448903
|Zagreb, Croatia |
|Warsaw, Poland |
|Timisoara, Romania |
|St. Petersburg, Russian Federation |
|Belgrade, Serbia |
|Madrid, Spain |
Rovi Pharmaceuticals Laboratories
||JR March, MD
||Getafe Hospital, E-28905 Getafe (Madrid) Spain
||J Marinel-lo, MD
||Mataró Hospital, E-08304 Mataro (Barcelona) Spain
||R Gómez Medialdea, MD
||Virgen de la Victoria Hospital, E-29010 Malaga, Spain
No publications provided
||Rovi Pharmaceuticals Laboratories, Medical Department
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 15, 2007
||March 16, 2011
||Spain: Spanish Agency of Medicines
Keywords provided by Rovi Pharmaceuticals Laboratories:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 31, 2014
Endocrine System Diseases