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
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
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
NCT ID
NCT00399425
First Posted
November 13, 2006
Last Updated
November 13, 2006
Sponsor
Spanish National Health System
Collaborators
Carlos III Health Institute, Rovi Pharmaceuticals Laboratories
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.
Results Reference
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Learn more about this trial
Efficacy of a Low-Molecular-Weight Heparin (Bemiparin) in the Treatment of Chronic Foot Ulcers in Diabetic Patients
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