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

Not Applicable

Completed

• Conditions: Neuropathic Diabetic Ulcer - Foot

• Registration Number: NCT02145962
• Lead Sponsor: Autonomous University of Morelos

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).

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-05
• Study First Submitted: 2014-05-16
• Study First Submitted QC: 2014-05-20
• Last Update Submitted: 2014-05-20
• Study First Posted: 2014-05-23
• Last Update Posted: 2014-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diabetic foot ulcer healing time	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.

Secondary Outcome Measures

Name	Time	Method
Adverse events	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.

Trial Locations

Locations (2)

Hospital General Regional No. 1 "Ignacio García Tellez" IMSS; 🇲🇽 Cuernavaca, Morelos, Mexico

Medical Services of the Autonomous University of Nuevo Leon; 🇲🇽 Monterrey, Nuevo Leon, Mexico