Open Multi-center Safety & Efficacy Study of Low Frequency Magnetic Fields to Treat Unresponsive Diabetic Foot Ulcers.
NCT ID: NCT02145962
Last Updated: 2014-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2006-12-31
2014-01-31
Brief Summary
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Detailed Description
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Two ELF-MF investigational exposure systems will be used to stimulate blood at different anatomical regions to enhance wound healing upon peripheral blood mononuclear cell migration to the ulcer site. a) In Monterrey, Nuevo Leon, where DFU subjects should be exposed at either forearm with a sinusoidal oscillating magnetic field of 120 Hz with nominal ELF-MF amplitude of approximately 0.6mT-0.8mT (6-8 Gauss) RMS 2 hours/day, 2 times/week. and b) In Cuernavaca, Morelos, where DFU subjects would be exposed at the thorax with a stimulation system in a quasi-Helmholtz configuration, for 25 minutes/day, 2 times/week to a sinusoidal oscillating magnetic field of 120 Hz, with nominal ELF-MF amplitude of approximately 0.6mT-0.8mT (6-8 Gauss) RMS. Treatment period for both groups will be 14.2 weeks or upon a complete healing. In each treatment session, evolution of ulcer healing should be recorded photographically.
Efficacy and adverse effects will be searched for during treatment, short-term (\<1 year), and long-term follow-up in both groups (up to 7 years).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Forearm tissue exposure with ELF-MF
This study arm should include subjects with diabetic foot ulcers recruited at the medical services site of the Autonomous University of Nuevo Leon, Monterrey, Mexico. These study patients should receive treatment in the forearm region.
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.
Thorax tissue exposure with ELF-MF
This study arm should include subjects with diabetic foot ulcers recruited at the IMSS Regional General Hospital N. 1 and Servicios de Salud de Morelos, Cuernavaca, Mexico. These study patients received treatment in the thorax region.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Presence of diabetic foot ulcers resistant to medical and/or surgical treatment
* Medical care prior to admission.
Exclusion Criteria
* Cancer diagnosis
* BMI \> 3
* Non-diabetic leg ulcers
* Infected wounds
* Skin autoimmune disease
* Vasculitis
20 Years
ALL
No
Sponsors
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Universidad Autonoma de Nuevo Leon
OTHER
Instituto Mexicano del Seguro Social
OTHER_GOV
Autonomous University of Morelos
OTHER
Responsible Party
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Luis Enrique Alberto Cañedo Dorantes
Research Professor, MD PhD
Principal Investigators
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Luis E Canedo Dorantes, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Autonomous University of Morelos
Guillermo Cabrera Alvarez, MD
Role: STUDY_CHAIR
Instituto Mexicano del Seguro Social
Rogelio Salinas Dominguez, MD
Role: STUDY_CHAIR
Universidad Autonoma de Nuevo Leon
Locations
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Hospital General Regional No. 1 "Ignacio García Tellez" IMSS
Cuernavaca, Morelos, Mexico
Medical Services of the Autonomous University of Nuevo Leon
Monterrey, Nuevo León, Mexico
Countries
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References
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Canedo-Dorantes L, Garcia-Cantu R, Barrera R, Mendez-Ramirez I, Navarro VH, Serrano G. Healing of chronic arterial and venous leg ulcers through systemic effects of electromagnetic fields [corrected]. Arch Med Res. 2002 May-Jun;33(3):281-9. doi: 10.1016/s0188-4409(02)00357-0.
Other Identifiers
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AVANCE-C2005-219
Identifier Type: OTHER
Identifier Source: secondary_id
ELF-MF-2006-001
Identifier Type: -
Identifier Source: org_study_id
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