Scientific validation TMR®

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Monocentric study on surgical patients

The study was conducted by Prof. A. Piaggesi at the University of Pisa (Italy) and showed statistically significant evidence of acceleration in wound healing (1). The results were published by an important scientific journal called “The International Journal of Lower Extremity Wounds” at the end of March 2015.

Methods
Two groups of 10 patients, admitted for surgery, were selected to check some clinical and biological parameters that changed due to the effect of TMR therapy:

  • Both groups of type 2 diabetic patients with post-surgical lesions with a similar area greater than 1 cm2, located distal to the ankle and with a low level of ischemia.
  • Both groups received standard treatment (initial surgical debridement, revascularization, if necessary, and Hydrofiber bandage).
  • One group received additional TMR® treatment for two consecutive weeks.

Results
The reported results showed an increase in a cure rate, a reduction in terms of wound surface area and a reduction in pain, as can be seen in the following graphs extracted from the published study.

The healing parameters that improved with TMR therapy were:

      • The 6-month cure rate was 90% in the TMR® group and 30% in the group treated only with standard single treatment (statistically significant; p <0.05).
      • The healing time in the TMR® treated group was 84.46 days (with a standard deviation of 54.38) versus 148.54 days (with a standard deviation of 78.96) for the control group (statistically significant; p <0.01).
      • At the end of a 12-month follow-up period all patients in the treated group were cured, while in the control group three patients were still ulcerated.
      • Pain measured with the VAS scale was significantly reduced (p <0.05) faster in the TMR® treated group than in the group that received the standard treatment alone, in the first 3 months of follow-up.

The statistically relevant results of this clinical study have allowed us to observe that the TMR® treatment added to the standard treatments allows to get faster than the standard therapy alone.

Multicenter exploratory clinical study
Clinical experience in using TMR® has been proven in a double-blind exploratory clinical study, in which a drastic reduction in the surfaces and volumes of patient injuries was highlighted (compared to standard treatment only).

157 patients were enrolled in 3 centers:

  1. Pisa (Cisanello – Prof. A. Piaggesi),
  2. Treviso (Cà Foncello Hospital – Dr. M.Sambataro),
  3. Peschiera del Garda VR (Nursing Home Pederzoli – Dr. C.Nicoletti).

In a moderately ischemic subgroup, the marked greater reduction of the lesion area (75% versus 19% of the control group) with placebo device, pain reduction (VAS scale), edema, necrotic tissue and increase in granulation tissue are highlighted.

The results of these studies were published in December 2016 in the Journal of Wound Care (JWC) with the title: “Safety and Effectiveness of Therapeutic Magnetic Resonance in the Management of Postsurgical Lesion of the Diabetic Foot”. (2)

In vivo biopsy study

Tests performed on biopsies have shown how treatment with TMR® has produced a statistically significant increase in proliferative cells such as keratinocytes, endothelial cells and fibroblasts, in treated patients, acting simultaneously in reducing inflammation and therefore inflammatory infiltrate.

After 15 days of treatment with TMR®, histopathological analyzes revealed a reorganization and differentiation of the tissue with the formation of dermal papillae and new blood vessels.

The results of these studies were reviewed by the “Regenerative Medicine” magazine in June 2015. The provisional title of the article is: “Histological and molecular analyzes of granulation tissue of diabetic foot ulcers treated with TMR”.

The article also included the results of gene expression of growth factors relevant for cell proliferation and wound healing. In fact, some factors have shown significant over-expression in patients treated with TMR® compared to untreated.

(1) Source: Lorenza Abbruzzese, DPM, Elisabetta Iacopi, MD, Alberto Coppelli, MD, Giovanni Bonino, DPM, Chiara Goretti, MD, and Alberto Piaggesi, MD,Safety and Effectiveness of Therapeutic Magnetic Resonance in the Management of Postsurgical Lesion of the Diabetic Foot, The International Journal of Lower Extremity Wounds, March 2015.14: 4-10.

(2) Source: A. Piaggesi, MD; M. Sambataro, MD; C Nicoletti, MD; C. Goretti, MD; E. Lacopi, MD; A. Coppelli, MD, Safety and effectiveness of therapeutic magnetic resonance in diabetic foot ulcers: a prospective randomised controlled trial, Journal of Wound Care, Vol 25 , No 12 , December 2016.

University of Padua – Italy.
Prof. Rizzuto, Prof. Zavan Department of Biomedical Sciences
In vitro test

In vitro tests in healthy and diabetic tissues have shown an increase in the proliferation of fibroblasts and endothelial cells after exposure to the TMR® treatment.
Preliminary results have shown that the TMR method, through daily treatments, promotes an increase in the proliferation of fibroblasts and endothelial cells, the type of cells that are involved in wound healing processes.

These results were published online on June 5, 2015 by the scientific journal “Journal of Tissue Engineering and Regenerative Medicine” with IF 5.199. The scientific article with all the results is titled “Treatment by Therapeutic Magnetic Resonance increases fibroblastic activity and keratinocyte differentiation in an in vitro model of 3D artificial skin”.

As a further positive signal, exposure to TMR® has also shown a reduction in the condition of oxidative stress in both fibroblasts and endothelial cells (3).

Following some indications from patients who used the device and the abundant literature on the subject, tests were carried out to verify the effectiveness of the electromagnetic fields of TMR® in bone cells.

The study containing the results of these tests highlights how TMR® is able to induce
the increased proliferation of osteocytes and the overexpression of the main osteogenic genes
, in particular osteocalcin, osteonectin, ostepontin and alkaline phosphatase. TMR® also promotes the deposition of hydroxyapatite crystals at the bone matrix level. This study was published in March 2016 in the journal Life sciences with the title: “Pulsed magnetic therapy increases osteogenic differentiation of mesenchymal stem cells only if they are pre-committed”. (4)

(3) Source: Ferroni L, Bellin G, Emer V, Rizzuto R, Isola M, Gardin C, Zavan B, Treatment by Therapeutic Magnetic Resonance (TMR ™) increases fibroblastic activity and keratinocyte differentiation in an in vitro model of 3D artificial skin, J Tissue Eng Regen Med. 2015 Jun 5. doi: 10.1002 / term.203

(4)Source: Letizia Ferroni, Ilaria Tocco, Andrea De Pieri, Martina Menarin, Enrico Fermi, Adriano Piattelli, Chiara Gardin, Barbara Zavan. Pulsed magnetic therapy increases osteogenic differentiation of mesenchymal stem cells only if they are pre-committed, Life Sciences 152(2016) 44–51

Bogolyubov Institute of Theoretical Physics of Kiev – Ukraine.
Prof. Brizhik.

Identification of the mechanisms of interaction between pulsating magnetic fields (PEMF) and redox processes in body tissues.

Prof. Brizhik is collaborating with the University of Padua, Department of Biomedical Sciences, to explain how TMR® therapy with low intensity magnetic fields, well-defined oscillating frequencies, is able to influence biological processes such as the healing of soft tissue.

A review of the literature conducted by Prof. Larissa Brizhik on the interaction of PEMFs with biological tissues was published on November 26, 2014, in the journal “Journal of Advances in Physics” (5).

An article (6) has also been published in the “International Journal of Biophysics” that describes the principle of biophysical functioning of TMR® therapy. The article clarifies how starting from clinical evidence it was possible to formulate a theory involving the influence of electromagnetic fields at the cellular level through a form of energy transport discovered in 1834 by Scott Russel: the soliton. The approach developed by Prof. Brizhik and Eng. E. Fermi is supported by several ongoing biological and clinical studies. The title of the article is “On the Mechanisms of Wound Healing by Magnetic Therapy: The Working Principle of Therapeutic Magnetic Resonance”.

(5) Fonte: L. Brizhik, Effects of magnetic fields on soliton mediated charge transport in biological systems, Journal of advances in Physics, Vol.6, No.2, 26 November 2014, 1191-1201.

(6) Fonte: Larissa Brizhik, Letizia Ferroni, Chiara Gardin, Enrico Fermi, On the Mechanisms of Wound Healing by Magnetic Therapy: The Working Principle of Therapeutic Magnetic Resonance, International Journal of Biophysics 2016, 6(3): 27-43


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