Safety and Effectiveness of Therapeutic Magnetic Resonance in the Management of Postsurgical Lesion of the Diabetic Foot

Abstract

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/m(2)), 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.

Guidelines on use of interventions to enhance healing of chronic foot ulcers in diabetes (IWGDF 2019 update)

“…All were of high risk of bias or showed no evidence of benefit. One RCT study of therapeutic magnetic resonance therapy was at low risk of bias but showed no benefit on the healing of DFUs despite the promise of an earlier pilot …”

“…One RCT study of therapeutic magnetic resonance therapy 107 was at low risk of bias but showed no benefit on the healing of DFUs despite the promise of an earlier pilot. 108 Overall, because of poor study design, it was concluded that there was little evidence to recommend the use of mechanical and physical therapies in the management of hard-to-heal diabetic foot ulcers. Rationale.…”

Treatment of diabetic foot ulcers with Therapeutic Magnetic Resonance (TMR®) improves the quality of granulation tissue

“… 10-12 In particular, experiences in clinical settings have confirmed the safety and effectiveness of PEMFs through Therapeutic Magnetic Resonance (TMR R ) in promoting tissue repair in post-traumatic and chronic wounds, making this technology potentially interesting for the management of DFUs and post-surgical wounds. 13 , 14 Furthermore, in an i n vitro dermal-like tissue, we have previously demonstrated that TMR R enhances skin wound healing improving the quality of the extracellular matrix (ECM) and reducing ROS, leading to a positive rejuvenation effect on cells. 15 In the present work, we investigated, under clinical, cellular and molecular biology point of view, the influence of PEMFs on wound healing process in consecutive Type-2 diabetic patients, studying the granulation tissue of DFUs treated with TMR R .…”

Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: a systematic review

“…One RCT on static magnetic therapy had a small sample size, randomization did not control for baseline differences between the two groups, and therefore, the results are difficult to interpret . A multicentre double‐blind RCT with a low risk of bias comparing twice daily application of therapeutic magnetic resonance for 4 weeks to usual care did not find a difference in ulcer healing at 10 weeks of follow‐up, in contrast to the findings from an earlier smaller, open observational pilot study …”

“…194 A multicentre doubleblind RCT with a low risk of bias comparing twice daily application of therapeutic magnetic resonance for 4 weeks 195 to usual care did not find a difference in ulcer healing at 10 weeks of follow-up, in contrast to the findings from an earlier smaller, open observational pilot study. 196…”