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
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.
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).
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01396837 -
Safety Trial of the RedDress Wound Care System (RD1) in Management of Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.
|
Phase 2 |