Clinical trial NCT02145962: Open Multi-center Safety & Efficacy Study of Low Frequency Magnetic Fields to Treat Unresponsive Diabetic Foot Ulcers.
Official title: Application of Extremely Low Frequency Electromagnetic Fields in the Cicatrization of Ulcers With Diabetic Origin as a Method of Preventive and Complementary Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Diabetic Ulcer - Foot
Keywords: diabetic foot ulcer healing
magnetic therapy
safety and efficacy
wound care
Lead sponsor: Autonomous University of Morelos
Sponsor class: OTHER
Collaborators: name: Universidad Autonoma de Nuevo Leon
name: Instituto Mexicano del Seguro Social
First posted: 2014-05-23
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Age older than 20 years old
* Presence of diabetic foot ulcers resistant to medical and/or surgical treatment
* Medical care prior to admission.

Exclusion Criteria:

* Pregnant women
* Cancer diagnosis
* BMI \> 3
* Non-diabetic leg ulcers
* Infected wounds
* Skin autoimmune disease
* Vasculitis

Primary outcomes:
measure: Diabetic foot ulcer healing time
timeFrame: 14.2 weeks or upon complete ulcer healing
Secondary outcomes:
measure: Adverse events
timeFrame: Two periods: 1 year and up to 7 years
Other outcomes:
Locations:
city: Cuernavaca
country: Mexico
facility: Hospital General Regional No. 1 "Ignacio García Tellez" IMSS
state: Morelos
city: Monterrey
country: Mexico
facility: Medical Services of the Autonomous University of Nuevo Leon
state: Nuevo Leon
Study officials:
affiliation: Autonomous University of Morelos
name: Luis E Canedo Dorantes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Mexicano del Seguro Social
name: Guillermo Cabrera Alvarez, MD
role: STUDY_CHAIR
affiliation: Universidad Autonoma de Nuevo Leon
name: Rogelio Salinas Dominguez, MD
role: STUDY_CHAIR
References:
citation: 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.