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

Primary Purpose

Foot Ulcer, Diabetic, Diabetic Angiopathies

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
bemiparin (low molecular weight heparin)
Sponsored by
Spanish National Health System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Ulcer, Diabetic focused on measuring Heparin, Low-Molecular-Weight, Bemiparin, Foot Ulcer, Diabetic, Diabetic Angiopathies, Primary Health Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Ulcer area
    Stage in Wagner's classification

    Secondary Outcome Measures

    Adverse effects
    Quality of life

    Full Information

    First Posted
    November 13, 2006
    Last Updated
    November 13, 2006
    Sponsor
    Spanish National Health System
    Collaborators
    Carlos III Health Institute, Rovi Pharmaceuticals Laboratories
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00399425
    Brief Title
    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

    2. Study Status

    Record Verification Date
    November 2006
    Overall Recruitment Status
    Terminated
    Study Start Date
    June 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2004 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Spanish National Health System
    Collaborators
    Carlos III Health Institute, Rovi Pharmaceuticals Laboratories

    4. Oversight

    5. 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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Foot Ulcer, Diabetic, Diabetic Angiopathies
    Keywords
    Heparin, Low-Molecular-Weight, Bemiparin, Foot Ulcer, Diabetic, Diabetic Angiopathies, Primary Health Care

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    84 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    bemiparin (low molecular weight heparin)
    Primary Outcome Measure Information:
    Title
    Ulcer area
    Title
    Stage in Wagner's classification
    Secondary Outcome Measure Information:
    Title
    Adverse effects
    Title
    Quality of life

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Manuel Rullan, MD
    Organizational Affiliation
    Primary health care of Mallorca. Ibsalut.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12765594
    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.
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    Efficacy of a Low-Molecular-Weight Heparin (Bemiparin) in the Treatment of Chronic Foot Ulcers in Diabetic Patients

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