Therapeutic Magnetic Resonance for diabetic foot ulcers

NewsBot · Feb 28, 2015

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Safety and Effectiveness of Therapeutic Magnetic Resonance in the Management of Postsurgical Lesion of the Diabetic Foot
Lorenza Abbruzzese, DPM; Elisabetta Iacopi, MD; Alberto Coppelli, MD; Giovanni Bonino, DPM; Chiara Goretti, MD; Alberto Piaggesi, MD
International Journal of Lower Extremity Wounds February 26, 2015

To evaluate the safety and effectiveness of therapeutic magnetic resonance (TMR) in the management of the diabetic foot (DF), we treated a group of consecutive type 2 diabetic inpatients with wide postsurgical lesions (Group A: N = 10; age 67.7 ± 18.9 years, duration of diabetes 22.3 ± 6.6 years, 8.1 ± 1.1%, body mass index 29.4 ± 2.1 kg/m2), for 2 consecutive weeks, while admitted, with a low-intensity magnetic resonance equipment, in addition to standard treatment. Patients, compared with a matched control group with the same clinical characteristics (Group B), were then followed monthly for 6 months to evaluate healing rate (HR), healing time (HT), rate of granulation tissue (GT) at 3 months, and adverse events. HR was of 90% in Group A and 30% in Group B (P < .05); GT was 73.7 ± 13.2% in Group A versus 51.84 ± 18.77% in Group B (P < .05). HT in Group A was 84.46 ± 54.38 days versus 148.54 ± 78.96 days in Group B (P < .01). No difference in adverse events (5 in Group A and 6 in Group B) was observed throughout the study period. In this pilot study, the use of TMR at this dose and duration was safe. The results also permit the observation that TMR plus standard care offered a faster healing rate compared with standard care alone.
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shoe07039 · Mar 2, 2015

did the faster time justify the cost.

docbourke · Mar 8, 2015

What are the characteristics of Gp B. Are they really a matched group?

NewsBot · Aug 1, 2015

Efficacy and Safety Evaluation of Systemic Extremely Low Frequency Magnetic Fields Used in the Healing of Diabetic Foot Ulcers-Phase II Data.
Ca?edo-Dorantes L et al
Arch Med Res. 2015 Jul 27.

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 complication
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NewsBot · Dec 16, 2016

Safety and effectiveness of therapeutic magnetic resonance in diabetic foot ulcers: a prospective randomised controlled trial.
Piaggesi A et al
J Wound Care. 2016 Dec 2;25(12):704-711.

OBJECTIVE:
To test the efficacy and safety of therapeutic magnetic resonance (TMR) in the management of diabetic foot ulcers (DFU), the authors designed a prospective randomised controlled trial in three highly specialised diabetic foot clinics.
METHOD:
All the patients consecutively visited in a period of 18 months were screened according to the inclusion (presence of an ulcer >1 cm2 in the foot lasting at least 6 weeks; ABPI>0.6; consent to participate in the study) and exclusion (Charcot's foot; local or systemic infections; chronic renal failure; any wearable electrically-driven life-supporting device) criteria. Patients, who were treated according to international guideline protocols, were randomised into two groups: group A received for four weeks the sham application of TMR, while group B received the active TMR for the same period. People were followed-up to 10 weeks and healing rate (HR), healing time (HT), rate of granulation tissue on wound bed (% GT), reduction of the area of the lesion (∆AL) and a score (0-3) evaluating erythema, oedema, pain and tenderness, respectively, were measured. Adverse events (AE) were registered and monitored throughout the study.
RESULTS:
No differences were observed in HR, HT and ∆AL between the two groups during follow-up, while % GT and the scores for erythema, oedema and pain at 10 weeks showed significant (p<0.05) improvements in group B compared with group A and versus baseline. When restricted to non-ischaemic patients (ABPI>0.8), ∆AL was significantly (p<0.05) more pronounced in group B than in group A. No difference in AE occurrence was observed between the two groups.
CONCLUSION:
Our study, despite not being able to demonstrate the effectiveness of TMR on healing rate at 10 weeks, with 4 weeks of active treatment in neuro-ischaemic DFUs, shows positive effects on clinical aspects of the DFU and is associated with a significant increase of GT in the wound bed.
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NewsBot · Oct 20, 2017

Treatment of diabetic foot ulcers with Therapeutic Magnetic Resonance (TMR®) improves the quality of granulation tissue.
Ferroni L, Gardin C, De Pieri A, Sambataro M, Seganfreddo E, Goretti C, Iacopi E, Zavan B, Piaggesi A.
Eur J Histochem. 2017 Aug 7;61(3):2800. doi: 10.4081/ejh.2017.2800.

Diabetic foot ulcers (DFUs) often result in severely adverse outcomes, such as serious infections, hospitalization, and lower extremity amputations. In last few years, to improve the outcome of DFUs, clinicians and researchers put their attention on the application of low intensity pulsating electro-magnetic fields through Therapeutic Magnetic Resonance (TMR®). In our study, patients with DFUs have been divided into two groups: The Sham Group treated with non-functioning TMR® device, and the Active Group treated with a functioning device. Biopsies were recovered from ulcers before and after a 15-day treatment with both kind of TMR® device. To recognize signs of inflammation or healing process, the harvested biopsies were subjected to histological and molecular analyses. The histological analysis showed a change in cell population after treatment with TMR®: an increase of fibroblasts and endothelial cells with a reduction of inflammatory cells. After TMR® application, the gene expression profile analysis revealed an improvement in extracellular matrix components such as matrix metalloproteinases, collagens and integrins, a reduction in pro-inflammatory interleukins, and an increase in growth factors expression. In conclusion, our research has identified histological and molecular features of reduced inflammation and increased cell proliferation during the wound healing process in response to TMR® application
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