Efficacy of a Low-Molecular-Weight Heparin (Bemiparin) in the Treatment of Chronic Foot Ulcers in Diabetic Patients

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

Status Terminated

Clinical Trial Summary

To assess the efficacy of bemiparin (low molecular weight heparin) for 3 months in the treatment of chronic foot ulcers in diabetic patients.

Clinical Trial Description

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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Angiopathies
• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer

• NCT number: NCT00399425
• Study type: Interventional
• Source: Spanish National Health System
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: June 2001
• Completion date: April 2004