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
  Purpose

To assess the efficacy of bemiparin (low molecular weight heparin) for 3 months in the treatment of chronic foot ulcers in diabetic patients.


Condition Intervention Phase
Foot Ulcer, Diabetic
Diabetic Angiopathies
Drug: bemiparin (low molecular weight heparin)
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Spanish National Health System:

Primary Outcome Measures:
  • Ulcer area
  • Stage in Wagner's classification

Secondary Outcome Measures:
  • Adverse effects
  • Quality of life

Estimated Enrollment: 84
Study Start Date: June 2001
Estimated Study Completion Date: April 2004
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00399425

Sponsors and Collaborators
Spanish National Health System
Carlos III Health Institute
Rovi Pharmaceuticals Laboratories
Investigators
Principal Investigator: Manuel Rullan, MD Primary health care of Mallorca. Ibsalut.
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00399425     History of Changes
Other Study ID Numbers: APM/00/PD1, AEM 01-0167
Study First Received: November 13, 2006
Last Updated: November 13, 2006
Health Authority: Spain: Primary Health Care of Mallorca, Ibsalut
Spain: Spanish Agency of Medicines and Medical Devices

Keywords provided by Spanish National Health System:
Heparin, Low-Molecular-Weight
Bemiparin
Foot Ulcer, Diabetic
Diabetic Angiopathies
Primary Health Care

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Diabetic Angiopathies
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 01, 2014