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

NACompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

January 31, 2014

Study Completion Date

January 31, 2014

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.

Trial Locations (2)

62450

"Hospital General Regional No. 1 Ignacio García Tellez IMSS", Cuernavaca

64000

Medical Services of the Autonomous University of Nuevo Leon, Monterrey

All Listed Sponsors
collaborator

Universidad Autonoma de Nuevo Leon

OTHER

collaborator

Instituto Mexicano del Seguro Social

OTHER_GOV

lead

Autonomous University of Morelos

OTHER

NCT02145962 - Open Multi-center Safety & Efficacy Study of Low Frequency Magnetic Fields to Treat Unresponsive Diabetic Foot Ulcers. | Biotech Hunter | Biotech Hunter