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

Neuropathic Diabetic Ulcer - Foot Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145962
• Other study ID #: ELF-MF-2006-001
• Secondary ID: AVANCE-C2005-219
• Status: Completed
• Phase: N/A
• First received: May 16, 2014
• Last updated: May 20, 2014
• Start date: December 2006
• Est. completion date: January 2014

Study information

• Verified date: May 2014
• Source: Autonomous University of Morelos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Neuropathic Diabetic Ulcer - Foot
• Ulcer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Mexico	Hospital General Regional No. 1 "Ignacio García Tellez" IMSS	Cuernavaca	Morelos
Mexico	Medical Services of the Autonomous University of Nuevo Leon	Monterrey	Nuevo Leon

Sponsors (3)

Lead Sponsor	Collaborator
Autonomous University of Morelos	Instituto Mexicano del Seguro Social, Universidad Autonoma de Nuevo Leon

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

Cañedo-Dorantes L, García-Cantú R, Barrera R, Méndez-Ramírez 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. Erratum in: Arch Med Res 2002 Sep-Oct;33(5):513. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes