Overview

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.