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

Sponsor

Spanish National Health System (Other)

Overall Status

Terminated

CT.gov ID

NCT00399425

Collaborator

Carlos III Health Institute (Other), Rovi Pharmaceuticals Laboratories (Industry)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Foot Ulcer, Diabetic Diabetic Angiopathies	Drug: bemiparin (low molecular weight heparin)	Phase 2/Phase 3

Detailed 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

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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

Study Start Date :

Jun 1, 2001

Study Completion Date :

Apr 1, 2004

Outcome Measures

Primary Outcome Measures

Ulcer area []
Stage in Wagner's classification []

Secondary Outcome Measures

Adverse effects []
Quality of life []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.