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Safety and effectiveness of therapeutic magnetic resonance in diabetic foot ulcers: a prospective randomised controlled trial.

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.


DECLARATION OF INTEREST
The study has been fully sponsored by Thereson S.p.A., manufacturer of TMR devices.