Single-center 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 (1). The results were published by a leading 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 as a result of TMR therapy:

• Both groups of type 2 diabetic patients with post-surgical lesions with 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 bandaging).
  One group received additional treatment with TMR® for two consecutive weeks.

Results
The reported results showed an increased a healing rate, a reduction in 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:

• Healing Rate at 6 months was 90% in the TMR®-treated group and 30% in the group treated only with single standard treatment (statistically significant; p < 0.05).
  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 healed, while three patients in the control group were still ulcerated.
  Pain measured by VAS scale was significantly (p < 0.05) reduced faster in the TMR®-treated group than in the group that received standard treatment alone, in the first 3 months of follow-up.

The statistically significant results of this clinical study observed that TMR® treatment supplementary to standard care achieves healing faster than standard therapy alone.

Multicenter exploratory clinical study
Clinical experience in using TMR® was proven in a double-blind exploratory clinical study, in which a dramatic reduction in patients’ lesion areas and volumes (compared with standard treatment alone) was shown.

A total of 157 patients were enrolled in 3 centers:

• Pisa (Cisanello – Prof. A. Piaggesi),
  Treviso (Ca’ Foncello Hospital – Dr. M.Sambataro),
  Peschiera del Garda VR (Casa di Cura Pederzoli – Dr. C.Nicoletti).

In a moderately ischemic subgroup, the markedly greater reduction in lesion area (75% vs. 19% in the control group) with sham device, reduction in pain (VAS scale), edema, necrotic tissue and increase in granulation tissue is shown.

The results of these studies were published in December 2016 in the Journal of Wound Care (JWC) under 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 showed that treatment with TMR® produced a statistically significant increase in proliferative cells such as keratinocytes, endothelial cells and fibroblasts, in treated patients, acting simultaneously in reducing inflammation and thus the inflammatory infiltrate.

After 15 days of TMR® treatment, histo-pathological analyses showed tissue reorganization and differentiation with the formation of dermal papillae and new blood vessels.

The results of these studies were submitted for review by the journal “Regenerative Medicine” in June 2015. The provissory title of the article is: “Histological and molecular analyses of granulation tissue of diabetic foot ulcers treated with TMR ”.

Gene expression results of growth factors relevant to cell proliferation and wound healing were also included in the article. Indeed, some factors showed significant overexpression in TMR®-treated patients compared with untreated patients.

(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) Fonte: 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.