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Open Multi-center Safety & Efficacy Study of Low Frequency Magnetic Fields to Treat Unresponsive Diabetic Foot Ulcers.

NCT02145962 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2014-05-23

No results posted yet for this study

Summary

An open multicenter trial to document the efficacy and safety of two therapeutic Extremely Low Frequency Magnetic Fields stimulation devices to promote wound healing of Diabetic Foot Ulcers.

Conditions

  • Neuropathic Diabetic Ulcer - Foot

Interventions

DEVICE

Forearm tissue exposure with ELF-MF

The treatment was delivered 2 hours/day, 2 times/week and consisted of sinusoidal oscillating magnetic fields of 120 Hz using a solenoid, with nominal field amplitude of approximately 0.6-0.8 mT (6-8 Gauss) RMS at the center of the stimulation system. The amount of blood exposed to the therapeutic ELF-MF using the forearm device is approximately 30 ml/min or 3.6 lt/session.

DEVICE

Thorax tissue exposure with ELF-MF

The treatment was delivered 25 minutes/day, 2 times/week and consisted of 120 Hz using a quasi-Helmholtz coil configuration, with nominal field amplitude of approximately 0.6-0.8 mT (6-8 Gauss) RMS at the center of the stimulation system. The amount of blood exposed to the therapeutic ELF-MF using the thorax device should be approximately 6,500 ml/min or 162.5 lt/session, which is approximately 45 times more blood volume stimulation per unit of time compared with the Forearm exposure system.

Sponsors & Collaborators

  • Universidad Autonoma de Nuevo Leon

    collaborator OTHER

  • Instituto Mexicano del Seguro Social

    collaborator OTHER_GOV

  • Autonomous University of Morelos

    lead OTHER

Principal Investigators

  • Luis E Canedo Dorantes, MD, PhD · Autonomous University of Morelos

  • Guillermo Cabrera Alvarez, MD · Instituto Mexicano del Seguro Social

  • Rogelio Salinas Dominguez, MD · Universidad Autonoma de Nuevo Leon

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02145962 on ClinicalTrials.gov