A Phase 2/3 interventional study of bemiparin (low molecular weight heparin) in Foot Ulcer, Diabetic and Diabetic Angiopathies, sponsored by Spanish National Health System. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-11-14.
Sponsored by Spanish National Health System · Phase 2/3, Interventional, and Treatment
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
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 84 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →This is the only study on the registry with Spanish National Health System as lead sponsor.
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Exclusion Criteria:
Ulcer area
Stage in Wagner's classification
Adverse effects
Quality of life
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This study is terminated, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.
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