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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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ClinicalTrials.gov 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

Tracking Information
First Submitted Date  ICMJE November 13, 2006
First Posted Date  ICMJE November 14, 2006
Last Update Posted Date November 14, 2006
Study Start Date  ICMJE June 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2006)
  • 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
 (submitted: November 13, 2006)
  • Adverse effects
  • Quality of life
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Foot Ulcer, Diabetic
  • Diabetic Angiopathies
Intervention  ICMJE Drug: bemiparin (low molecular weight heparin)
Study Arms  ICMJE Not Provided
Publications * 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.

*   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
 (submitted: November 13, 2006)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Spanish National Health System
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Carlos III Health Institute
  • Rovi Pharmaceuticals Laboratories
Investigators  ICMJE
Principal Investigator: Manuel Rullan, MD Primary health care of Mallorca. Ibsalut.
PRS Account 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