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

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
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00399425
Enrollment
84
Registered
2006-11-14
Start date
2001-06-30
Completion date
2004-04-30
Last updated
2006-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Angiopathies, Foot Ulcer, Diabetic

Keywords

Heparin, Low-Molecular-Weight, Bemiparin, Foot Ulcer, Diabetic, Diabetic Angiopathies, Primary Health Care

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.

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

Interventions

DRUGbemiparin (low molecular weight heparin)

Sponsors

Carlos III Health Institute
CollaboratorOTHER_GOV
Rovi Pharmaceuticals Laboratories
CollaboratorINDUSTRY
Spanish National Health System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Ulcer area
Stage in Wagner's classification

Secondary

MeasureTime frame
Adverse effects
Quality of life

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026