Clinical Trial to Evaluate the Efficacy and Safety of Sodium Bemiparin for Treatment of Diabetic Foot Ulcers

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rovi Pharmaceuticals Laboratories
• Treatments: Bemiparin; Heparin, Low-Molecular-Weight

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 <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.