Scientific Validation of TMR®
Single centre study of 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 *. The results were published by a major scientific journal, “The International Journal of Lower Extremity Wounds”, at the end of March 2015.
Two groups of 10 patients, admitted for surgery, were selected to check certain clinical and biological parameters which had changed due to TMR therapy effects:
- Both groups of patients had type 2 diabetes with post-surgical lesions with similar area greater than 1 cm2, located distal to the ankle and having a low level of ischemia.
- Both groups received standard treatment (initial surgical debridement, revascularisation, if necessary and Hydrofiber bandaging).
- One group received additional treatment with TMR® for two consecutive weeks.
The reported results showed an increased rate of healing, a reduction in terms of surface area of wounds and a reduction in pain, as can be seen in the graphs below, taken from the published study.
The healing parameters which improved with TMR® treatment were:
- The healing rate at 6 months was 90% in the group treated with TMR® and 30% in the group treated only with standard treatment (statistically significant, p <0.05).
- The healing time in the group treated with TMR® 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 period of follow-up of 12 months all patients in the treated group had healed, while in the control group three patients were still ulcerated.
- Pain measured by Visual Analogue Scale was reduced significantly (p <0.05) faster in the group treated with TMR® than the group that received only the standard treatment in the first 3 months of follow-up.
The statistically significant results of this clinical study allowed us to observe that TMR® treatment in addition to standard care allows for a faster healing than standard therapy alone.
Multicentre clinical exploratory trial
Clinical experience of TMR® use was ascertained in a double-blind exploratory clinical study, in which a drastic reduction in the area and volume of lesions of patients (compared to standard treatment alone) was observed.
157 patients were enrolled in 3 centres:
- Pisa (Cisanello – Prof. A. Piaggesi),
- Treviso (Cà Foncello Hospital – Dr. M.Sambataro),
- Peschiera del Garda VR (Casa di Cura Pederzoli – Dr. C.Nicoletti).
The results will be published shortly.
In vivo bioptic study
Tests performed on biopsies have demonstrated that treatment with TMR® produced a statistically significant increase in proliferative cells such as keratinocytes, endothelial cells and fibroblasts in treated patients, by acting simultaneously in reducing inflammation and therefore the inflammatory infiltrate.
After 15 days of treatment with TMR®, histo-pathological analyses showed a re-organisation and differentiation of tissue with the formation of dermal papillae and new blood vessels.
The results of these studies were sent for a review at the journal “Regenerative Medicine” in June 2015. The provisional title of the article is: “Histological and molecular analyses of granulation tissue of diabetic foot ulcers treated with TMR“.
The results of gene expression of growth factors relevant to cell proliferation and wound healing were also included in the article. Some factors have in fact shown, in patients treated with TMR®, a significant over expression compared to those not treated.
* Source: Lorenza Abbruzzese, DPM, Elizabeth 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.
University of Padua – Italy.
Prof. Rizzuto from The Prof. Zavan Department of Biomedical Sciences
In vitro tests
In vitro tests in healthy and diabetic tissues have shown an increase in the proliferation of fibroblasts and endothelial cells after exposure to TMR® treatment.
The preliminary results showed that the TMR method, through daily treatments, promotes an increase in the proliferation of fibroblasts and endothelial cells, types of cells which are involved in the processes of wound healing.
These findings were published online on 5 June 2015 in the scientific journal, “Journal of Tissue Engineering and Regenerative Medicine” with IF 5.199. The scientific article with all of 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® also showed a reduction of the oxidative stress condition in both fibroblasts and endothelial cells **.
** 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
Link Pubmed: http://www.ncbi.nlm.nih.gov/pubmed/26053437
Bogolyubov Institute for Theoretical Physics in Kiev – Ukraine. Prof. Brizhik
Identification of mechanisms of interaction between pulsating electromagnetic fields (PEMF) and redox processes in body tissues.
Prof. Brizhik is collaborating with University of Padua’s Department of Biomedical Sciences to explain how low intensity magnetic field TMR® with well-defined oscillating frequencies is able to influence biological processes such as the healing of soft tissue.
A literature review conducted by Professor Larissa Brizhik on the interaction of PEMF with biological tissues was published on 26 November 2014 in the “Journal of Advances in Physics”*.
In addition, an article describing the principle of biophysical mechanisms of TMR® therapy is under review in the journal “Electromagnetic Biology and Medicine”. The article explains how, starting from the clinical evidence, it has been possible to formulate a theory that involves the influence of electromagnetic fields at cellular level through a form of energy transport discovered in 1834 by Scott Russel: the soliton. The approach developed by Prof. Brizhik and the engineer E. Fermi is supported by the various ongoing biological and clinical studies. The provisional article title is “Working principle of TMR®, Therapeutic Magnetic Resonance“.
*** Source: 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.
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