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

Autonomous University of Morelos

Status: Completed

Conditions: Neuropathic Diabetic Ulcer - Foot

Treatments: Device: Forearm tissue exposure with ELF-MF; Device: Thorax tissue exposure with ELF-MF

Study type: Interventional

Funder types: Other

Identifiers

NCT02145962

AVANCE-C2005-219 (Other Identifier)

ELF-MF-2006-001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 27 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Forearm tissue exposure with ELF-MF

Active Comparator group

Description:

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.

Treatment:

Device: Forearm tissue exposure with ELF-MF

Thorax tissue exposure with ELF-MF

Active Comparator group

Description:

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.

Treatment:

Device: Thorax tissue exposure with ELF-MF