NCT00399425

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2001

Typical duration for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
Last Updated

November 14, 2006

Status Verified

November 1, 2006

First QC Date

November 13, 2006

Last Update Submit

November 13, 2006

Conditions

Foot Ulcer, DiabeticDiabetic Angiopathies

Keywords

Heparin, Low-Molecular-WeightBemiparinFoot Ulcer, DiabeticDiabetic AngiopathiesPrimary Health Care

Outcome Measures

Primary Outcomes (2)

  • Ulcer area

  • Stage in Wagner's classification

Secondary Outcomes (2)

  • Adverse effects

  • Quality of life

Interventions

bemiparin (low molecular weight heparin)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 12765594BACKGROUND

MeSH Terms

Conditions

Diabetic FootDiabetic Angiopathies

Interventions

bemiparinHeparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Manuel Rullan, MD

    Primary health care of Mallorca. Ibsalut.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 13, 2006

First Posted

November 14, 2006

Study Start

June 1, 2001

Study Completion

April 1, 2004

Last Updated

November 14, 2006

Record last verified: 2006-11