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

Application of Extremely Low Frequency Electromagnetic Fields in the Cicatrization of Ulcers With Diabetic Origin as a Method of Preventive and Complementary Treatment

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.

Study Overview

• Status: Completed
• Conditions: Neuropathic Diabetic Ulcer - Foot
• Intervention / Treatment: Device: Forearm tissue exposure with ELF-MF; Device: Thorax tissue exposure with ELF-MF

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).

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62450
      • Hospital General Regional No. 1 "Ignacio García Tellez" IMSS
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64000
      • Medical Services of the Autonomous University of Nuevo Leon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetic foot ulcer healing time	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.	14.2 weeks or upon complete ulcer healing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	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.	Two periods: 1 year and up to 7 years

Collaborators and Investigators

• Sponsor: Autonomous University of Morelos
• Collaborators: Instituto Mexicano del Seguro Social; Universidad Autonoma de Nuevo Leon
• Investigators: Principal Investigator: Luis E Canedo Dorantes, MD, PhD, Autonomous University of Morelos; Study Chair: Guillermo Cabrera Alvarez, MD, Instituto Mexicano del Seguro Social; Study Chair: Rogelio Salinas Dominguez, MD, Universidad Autonoma de Nuevo Leon

Publications and helpful links

General Publications

• 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. Erratum In: Arch Med Res 2002 Sep-Oct;33(5):513.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: May 16, 2014
• First Submitted That Met QC Criteria: May 20, 2014
• First Posted (Estimate): May 23, 2014

Study Record Updates

• Last Update Posted (Estimate): May 23, 2014
• Last Update Submitted That Met QC Criteria: May 20, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: wound care; safety and efficacy; magnetic therapy; diabetic foot ulcer healing
• Additional Relevant MeSH Terms: Pathologic Processes; Ulcer
• Other Study ID Numbers: ELF-MF-2006-001; AVANCE-C2005-219 (Other Identifier: National Council for Science and Technology Mexico (CONACYT))