Foot Ulcer, Diabetic Clinical Trial
Official title:
Triple-Blind Clinical Trial With Placebo Control to Evaluate the Efficacy of a Heparin of Low Molecular Weight (Bemiparin) for Treating Slow-Responding Ulcers in Diabetic Foot in Primary Care
To assess the efficacy of bemiparin (low molecular weight heparin) for 3 months in the treatment of chronic foot ulcers in diabetic patients.
The involvement of microcirculation in diabetes microangiopathy may be the cause of
ulceration and severe incapacitation. Torpid ulcers of the lower limbs affect up to 15% of
diabetic patients at some moment of their lifetime; about one-third of patients developing
ulcers will never achieve their definitive cure, and half of them will die within three
years .
Heparins, besides their well known antithrombotic effects, have been shown to stimulate both
the synthesis of heparan sulphate —a potent endogenous anticoagulant— in endothelial cell
cultures and the proliferation of fibroblasts taken from diabetic ulcers .
After noticing the highly positive evolution of chronic ulcers in six diabetic patients who
had received LMWHs in their homes for the prophylaxis of deep vein thrombosis , and
considering the excellent safety record of these drugs, we decided to explore the effects of
LMWHs on the evolution of diabetic foot ulcers and the quality of life of diabetic patients
seen in our primary care practices.
Comparison: bemiparin vs placebo
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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