Foot Ulcer, Diabetic
Conditions
Keywords
diabetic, foot, ulcer, bemiparin, neuropathy, neuroishemic, diabetes
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.
Interventions
DRUGBemiparin
Bemiparin sodium
DRUGPlacebo
Sodium Chloride 0,9%
Sponsors
Rovi Pharmaceuticals Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 90 day |
Secondary
| Measure | Time frame |
|---|---|
| incidence of major bleeding and the incidence of adverse events. | 210 day |
Countries
Croatia, Poland, Romania, Russia, Serbia, Spain
Outcome results
None listed