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 enrollmentMarch 2007

ConditionsFoot Ulcer, Diabetic

InterventionsPlacebo Bemiparin

DrugsBemiparin Placebo

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Foot Ulcer, Diabetic
Sponsor: Rovi Pharmaceuticals Laboratories
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.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

March 2007

End Date

April 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rovi Pharmaceuticals Laboratories

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 \<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.

Arms & Interventions

2

Placebo

Intervention: Placebo

A

Bemiparin

Intervention: Bemiparin

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