Open Multi-center Safety & Efficacy Study of Low Frequency Magnetic Fields to Treat Unresponsive Diabetic Foot Ulcers.
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Medical care prior to admission.
- Age older than 20 years old
- Presence of diabetic foot ulcers resistant to medical and/or surgical treatment
- Medical care prior to admission.
- Age older than 20 years old
- Presence of diabetic foot ulcers resistant to medical and/or surgical treatment
Exclusion Criteria
- Infected wounds
- Pregnant women
- Cancer diagnosis
- ...
- Infected wounds
- Pregnant women
- Cancer diagnosis
- Vasculitis
- Non-diabetic leg ulcers
- BMI > 3
- Skin autoimmune disease
Summary
- Conditions
- Neuropathic Diabetic Ulcer - Foot
- Type
- Interventional
- Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 125 years
- Gender
- Both males and females
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 Autonomo...
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).
Inclusion Criteria
- Medical care prior to admission.
- Age older than 20 years old
- Presence of diabetic foot ulcers resistant to medical and/or surgical treatment
- Medical care prior to admission.
- Age older than 20 years old
- Presence of diabetic foot ulcers resistant to medical and/or surgical treatment
Exclusion Criteria
- Infected wounds
- Pregnant women
- Cancer diagnosis
- ...
- Infected wounds
- Pregnant women
- Cancer diagnosis
- Vasculitis
- Non-diabetic leg ulcers
- BMI > 3
- Skin autoimmune disease
Tracking Information
- NCT #
- NCT02145962
- Collaborators
- Universidad Autonoma de Nuevo Leon
- Instituto Mexicano del Seguro Social
- 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
- 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
Get Well Soon