clinical trial to evaluate the efficacy and safety of sodium bemiparin for treatment of diabetic foot ulcers

Conditions: Foot Ulcer, Diabetic

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.


Eligibility 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 \ 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.

Keywords: diabetic foot ulcer bemiparin neuropathy neuroishemic diabetes