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

November 13, 2006
November 13, 2006
June 2001
Not Provided
  • Ulcer area
  • Stage in Wagner's classification
Same as current
No Changes Posted
  • Adverse effects
  • Quality of life
Same as current
Not Provided
Not Provided
 
Efficacy of a Low-Molecular-Weight Heparin (Bemiparin) in the Treatment of Chronic Foot Ulcers in Diabetic Patients
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

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

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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Foot Ulcer, Diabetic
  • Diabetic Angiopathies
Drug: bemiparin (low molecular weight heparin)
Not Provided
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. Spanish.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
84
April 2004
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00399425
APM/00/PD1, AEM 01-0167
Not Provided
Not Provided
Spanish National Health System
  • Carlos III Health Institute
  • Rovi Pharmaceuticals Laboratories
Principal Investigator: Manuel Rullan, MD Primary health care of Mallorca. Ibsalut.
Spanish National Health System
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP