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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00399425
Recruitment Status : Terminated
First Posted : November 14, 2006
Last Update Posted : November 14, 2006
Carlos III Health Institute
Rovi Pharmaceuticals Laboratories
Information provided by:
Spanish National Health System

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.

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

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : June 2001
Estimated Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Ulcer area
  2. Stage in Wagner's classification

Secondary Outcome Measures :
  1. Adverse effects
  2. Quality of life

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00399425

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

Publications: Identifier: NCT00399425     History of Changes
Other Study ID Numbers: APM/00/PD1
AEM 01-0167
First Posted: November 14, 2006    Key Record Dates
Last Update Posted: November 14, 2006
Last Verified: November 2006

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

Additional relevant MeSH terms:
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, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action