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

This study has been terminated.

Sponsor:

Collaborators:

Carlos III Health Institute

Rovi Pharmaceuticals Laboratories

Information provided by:

Spanish National Health System

ClinicalTrials.gov Identifier:

NCT00399425

First received: November 13, 2006

Last updated: NA

Last verified: November 2006

History: No changes posted

Tracking Information

First Received Date ^ICMJE

November 13, 2006

Last Updated Date

November 13, 2006

Start Date ^ICMJE

June 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Ulcer area
Stage in Wagner's classification

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Adverse effects
Quality of life

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Foot Ulcer, Diabetic
Diabetic Angiopathies

Intervention ^ICMJE

Drug: bemiparin (low molecular weight heparin)

Study Arm (s)

Not Provided

Publications *

Rullán M, Cerdà 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. Spanish.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Estimated Completion Date

April 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00399425

Other Study ID Numbers ^ICMJE

APM/00/PD1, AEM 01-0167

Has Data Monitoring Committee

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Spanish National Health System

Collaborators ^ICMJE

Carlos III Health Institute
Rovi Pharmaceuticals Laboratories

Investigators ^ICMJE

Principal Investigator:

Manuel Rullan, MD

Primary health care of Mallorca. Ibsalut.

Information Provided By

Spanish National Health System

Verification Date

November 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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