Arch Med Res. 2015 Aug;46(6):470-8.

Efficacy and Safety Evaluation of Systemic Extremely Low Frequency Magnetic Fields Used in the Healing of Diabetic Foot Ulcers-Phase II Data.

 

Cañedo-Dorantes L1, Soenksen LR2, García-Sánchez C3, Trejo-Núñez D4, Pérez-Chávez F5, Guerrero A6, Cardona-Vicario M4, García-Lara C4, Collí-Magaña D4, Serrano-Luna G7, Angeles Chimal JS4, Cabrera G8.
  • 1Department of Postgraduate Medicine, School of Medicine, Autonomous University of Morelos, Cuernavaca, Mexico. Electronic address: lscanedo@gmail.com.
  • 2Department of Biomedical Engineering, Monterrey Institute of Technology (ITESM), Mexico City, Mexico.
  • 3Department of Postgraduate Medicine, School of Medicine, Autonomous University of Morelos, Cuernavaca, Mexico; Department of Emergency Services, Servicios de Salud de Morelos, Cuernavaca, Morelos, Mexico.
  • 4Department of Postgraduate Medicine, School of Medicine, Autonomous University of Morelos, Cuernavaca, Mexico.
  • 5Department of Internal Medicine Medical Services of the Autonomous University of Nuevo Leon, Monterrey, Mexico.
  • 6Department of Emergency Services, Servicios de Salud de Morelos, Cuernavaca, Morelos, Mexico; Department of Angiology, Regional General Hospital No. 1, IMSS, Cuernavaca, Mexico.
  • 7Department of Bioelectronics, Mexican Society of Bioelectromagnetism, Mexico City, Mexico.
  • 8Department of Angiology, Regional General Hospital No. 1, IMSS, Cuernavaca, Mexico.

 

Abstract

BACKGROUND AND AIMS:

Cellular and animal models investigating extremely low frequency magnetic fields (ELF-MF) have reported promotion of leukocyte-endothelial interactions, angiogenesis, myofibroblast and keratinocyte proliferation, improvement of peripheral neuropathy and diabetic wound healing. In humans, it has also been reported that systemic exposure to ELF-MF stimulates peripheral blood mononuclear cells, promoting angiogenesis and healing of chronic leg ulcers. The aim of the study was to investigate the effect of exposing different blood volumes to specific ELF-MFs (120 Hz sinusoidal waves of 0.4-0.9 mT RMS) to induce healing of diabetic foot ulcers (DFUs).

METHODS:

Twenty six diabetic patients with non-responsive DFUs were divided into two exposure groups to receive treatment and record healing time. The forearm group, exposed to ELF-MF 2 h/day, twice weekly (3.6 l of blood/session); and the thorax group, exposed 25 min/day, 2 times/week (162.5 l of blood/session). Treatment period was 100 days or upon complete healing. Ulcer recurrences and adverse effects were investigated during short-term (<1 year) and long-term (3.4-7.8 years) follow-up.

RESULTS:

Mean healing time was 61.48 ± 33.08 days in the forearm group and 62.56 ± 29.33 days for the thorax group. No adverse effects or ulcer recurrences in the original ulcer site were reported during treatment, the short-term follow-up period or the long-term follow-up period in both groups.

CONCLUSIONS:

Healing time was independent of the amount of blood exposed to ELF-MF used in this trial. ELF-MFs are effective and safe and could be applied to non-healing DFUs in conjunction with other preventive interventions to reduce DFUs complications.

KEYWORDS:

Diabetes; Magnetic Therapy; Ulcer; Wound Healing

PMID: 26226416

 

Supplements:

Epidemiology. 15% of diabetic patients will develop chronic diabetic foot ulcers at some point in their lives. The prevalence of active ulcer in diabetic population has been estimated between 4% to 10% suggesting that life-time incidence could be as high as 25%. Mortality rates after ulceration are around 40% and up to 85% of diabetic related amputations are preceded by foot ulcers. Mortality following amputation could range as high as 39% to 80% at five years.

Causes. Chronic hyperglycemia and lipid abnormalities associated to Diabetes mellitus are responsible for complications such as macro and  microvascular    alterations,    peripheral    neuropathy    and  immune

abnormalities.    These    changes   bring about sensory loss, pain, foot deformity, callus formation, warm feet, dry, cracked skin reducction of bone perfusion, and likelihood of infection. In Diabetic foot patients, a small trauma could lead to non-healing diabetic foot ulcers.

Treatments. Prevention and early treatments of DFU are essential to control diabetic foot complications. Non-surgical treatments include: hydrocolloids, tissue engineering materials, growth factors, maggots, stem cells, off-loading non-removable casts, hyperbaric chamber, negative pressure, among others. There is no uniform consensus regarding the results of these treatments, and in practice their cost made them unreachable in the primary care centers of developing countries. In fact, patients normally take care of their ulcers at home where they frequently get infected. In the immune compromised diabetic patient this initial complications often end up in hospitalizations, amputations or even death.

Technology. Physics impact in modern medical practice is well known. This innovation is based on specially configured electromagnetic fields aimed to activate circulating peripheral blood mononuclear cells. Activated cells travel through the blood to the chronic wound where they liberate cytokines, growth factors and other mediators, stimulating the creation of new blood vessels, promote nerve regeneration and accelerate wound healing. This technology is not invasive, have not secondary negative effects, and its short-term efficacy is similar to presently accepted non-surgical treatments. We have followed patients for more than seven years without remission of the original treated ulcer. Applied to uncomplicated diabetic ulcers this technology improve cost and generate important savings avoiding more than 60% of hospitalization, amputations, rehabilitation treatments, prosthesis and liability costs.

This innovation has the following support:

Preclinical studies in cells and animals.

fig1

Phase I and Phase II clinical trials (~100 patients treated)

fig2

Phase III Clinical Research Protocols approved by the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) a decentralized organ of the Department of Health.

Design and construction of Prototypes that comply with the international Electrotechnical Commission standards for manufacture and use with patients.

fig3

Nine international patents (United States, Canada, Taiwan, China, Hong Kong, Japan, Korea)
. Two patents pending approval: (Brazil, México).

Patents value (Neopatents) Include Competitive Landscape, Freedom to operate, Patentability.

 

Scientific publications

The technology has been proved in two clinics designed for preventive care of patients with diabetic foot ulcers where a patient protocol that define appropriate interventions has been developed.

fig4

References

  1. Cañedo-Dorantes L, Soenksen LR, García-Sánchez C, Trejo-Núñez D, Pérez-Chávez F, Guerrero A, Cardona-Vicario M, García-Lara C, Collí-Magaña D, Serrano-Luna G, Angeles Chimal JS, Cabrera G. Efficacy and Safety Evaluation of Systemic Extremely Low Frequency Magnetic Fields Used in the Healing of Diabetic Foot Ulcers-Phase II Data. Arch Med Res. 2015 Aug;46(6):470-8. doi: 10.1016/j.arcmed.2015.07.002. Epub 2015 Jul 28.
  2. Cañedo L, García-Cantú R, Barrera R, Mendez-Ramirez I, Navarro VH, Serrano G. Healing of chronic arterial and venous leg ulcers through systemic effects of electromagnetic fields. Archives of Medical Research 2002; 33, 281-289.

 

Partially supported with Federal funds from CONACYT, Nacional Financiera and Secretaría de Economía: 2004 CONACYT-AVANCE C01-73; 2006 CONACYT-AVANCE 2005-219; 2008 CONACYT-NAFIN Programa Emprendedores; 2009 CONACYT-Secretaría de Economía PEI 113823; 2009 Fondo Sectorial Salud y Seguridad Social 115231; 2010 Secretaría de Economía FIT ECO-2010-C01-147125; 2011 CONACYT-SE PROINNOVA 157225; 2014 Secretaría de Economía FINNOVA 225493.

 

Contact                                                             

Luis Cañedo M.D. Ph.D.

School of Medicine,

Autonomous University of Morelos,

Cuernavaca, Mexico

lscanedo@gmail.com

Cell Phone 52777 1355089

 

 

Multiselect Ultimate Query Plugin by InoPlugs Web Design Vienna | Webdesign Wien and Juwelier SchönmannMultiselect Ultimate Query Plugin by InoPlugs Web Design Vienna | Webdesign Wien and Juwelier Schönmann