Clinical trial NCT00399425: Efficacy of a Low-Molecular-Weight Heparin (Bemiparin) in the Treatment of Chronic Foot Ulcers in Diabetic Patients
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Foot Ulcer, Diabetic
Diabetic Angiopathies
Keywords: Heparin, Low-Molecular-Weight
Bemiparin
Foot Ulcer, Diabetic
Diabetic Angiopathies
Primary Health Care
Lead sponsor: Spanish National Health System
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
name: Rovi Pharmaceuticals Laboratories
First posted: 2006-11-14
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Ulcer area
measure: Stage in Wagner's classification
Secondary outcomes:
measure: Adverse effects
measure: Quality of life
Other outcomes:
Locations:
Study officials:
affiliation: Primary health care of Mallorca. Ibsalut.
name: Manuel Rullan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rullan M, Cerda L, Frontera G, Llobera J, Masmiquel L, Olea JL. [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]. Aten Primaria. 2003 May 15;31(8):539-44. doi: 10.1016/s0212-6567(03)70729-x. Spanish.