NCT00448903CompletedPhase 3
Multicentric, Randomized, Double-blind, Controlled Clinical Trial to Assess the Efficacy and Safety of Bemiparin Sodium as Treatment of Diabetic Foot Ulcers
Rovi Pharmaceuticals Laboratories6 sites in 6 countries329 target enrollmentStarted: March 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 329
- Locations
- 6
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
2
Placebo Comparator
Placebo
Intervention: Placebo (Drug)
A
Experimental
Bemiparin
Intervention: Bemiparin (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- incidence of major bleeding and the incidence of adverse events.(210 day)
Investigators
Study Sites (6)
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