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

Spanish National Health System

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Foot Ulcer, Diabetic

Diabetic Angiopathies

Treatments

Drug: bemiparin (low molecular weight heparin)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00399425

AEM 01-0167

APM/00/PD1

Details and patient eligibility

About

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

Full 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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age over 18 years;
type I or II diabetes mellitus diagnosed (ADA 1998) for more than 3 years;
presence of at least one cutaneous ulcer distal to the knee, not involving deep tissues (stages I and II of Wagner's classification ) and existing for at least three months;
giving their written informed consent.

Exclusion criteria

hypersensibility to heparin or pig derivatives
body weight lower than 35 kg
presence of clinical signs of infection that did not resolve in spite of oral antibiotics;
anticoagulant therapy;
severe impairment of renal or hepatic function;
bleeding disorder;
active peptic ulcer;
arterial hypertension with poor control;
pregnancy or lactation;
terminal illness or a prognosis of survival under three months.