NCT Number: NCT02145962
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.
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Notify Me20 year and older
All sexes
Interventional
Not applicable
Hospital General Regional No. 1 "Ignacio García Tellez" IMSS, Cuernavaca, Morelos, Mexico
An open multi center trial to document the systemic effects and safety of Extremely Low Frequency Electromagnetic Fields (ELF-MF) stimulation on healing of Diabetic Foot Ulcers (DFU). The study will be performed in two sites: Monterrey, Nuevo Leon, with patients from Medical Services of the Autonomous University of Nuevo León, and Cuernavaca, Morelos with patients from Regional General Hospital of Cuernavaca N. 1 IMSS, and Health Services of Morelos.
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 14.2 weeks or upon complete ulcer healing
Healing time was defined as the period (in days) required for the completion of ulcer closure when applying electromagnetic field treatment. Treatment period end-point was 14.2 weeks or upon complete healing according to clinical inspection.
Time frame: Two periods: 1 year and up to 7 years
After treatment, follow-ups were performed to assess short-term (<1 year) and long-term safety (up to 7 years) after treatment. Adverse events were also assessed and defined as: a) Ulcer recurrences in the same site, b) Damage to an organ, c) Development of cancer or any other disease states possibly associated to the use of Extremely Low Frequency Magnetic Fields treatment.
Autonomous University of Morelos
Other
Application of Extremely Low Frequency Electromagnetic Fields in the Cicatrization of Ulcers With Diabetic Origin as a Method of Preventive and Complementary Treatment
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