Effect of Electromagnetic Field Therapy and Customized Foot Insole on Peripheral Circulation and Ankle–Brachial Pressure Index in Patients with Diabetic Foot Ulcer: A Randomized Controlled Clinical Trial

Abstract

<b>Background:</b> Diabetic foot ulcers (DFUs) are considered a prevalent complication of diabetes mellitus, frequently accompanied with compromised peripheral circulation, slower healing, as well as high risk of infection in addition to risk of amputation. Additional treatments that enhance microvascular perfusion and lessen plantar pressure may accelerate the healing process. This study was carried out to examine the impact of pulsed electromagnetic field (EMF) therapy as well as customized silicone gel insoles in terms of peripheral circulation in addition to vascular indices in patients with DFUs. <b>Methods:</b> A randomized, controlled clinical trial, including sixty-six adults diagnosed with type II diabetes as well as plantar DFUs (Wagner grade I-II) were divided into three groups (<i>n</i> = 22 each): Group A was given low-frequency electromagnetic field therapy (15-50 Hz, 2-5 mT, 30 min, three times per week for 8 weeks), Group B was given a customized silicone gel insoles produced for ulcer offloading, and Group C (control) was given conventional physiotherapy along with wound care. Peripheral microcirculation as well as tissue perfusion were the primary outcomes, and they were measured using Laser Doppler Flowmetry (LDF), Photoplethysmography (PPG), in addition to the Toe-Brachial Index (TBI). The secondary outcome included the Ankle-Brachial Pressure Index (ABPI). A blinded assessor measured the outcomes at the beginning of the study, after the intervention (week 8), and again after the follow-up (week 16). <b>Results:</b> EMF therapy significantly improved LDF (baseline: 45.2 ± 6.5 PU; week 8: 62.5 ± 7.2 PU), PPG (0.42 ± 0.08 mV to 0.68 ± 0.10 mV), TBI (0.64 ± 0.07 to 0.82 ± 0.08), and ABPI (0.88 ± 0.06 to 0.97 ± 0.05) compared with insoles and controls (<i>p</i> < 0.001, partial η² 0.25-0.37). The insole group exhibited moderate enhancements, whereas the control group demonstrated minor changes. Between-group analyses showed substantial differences in favor of EMF therapy across all measured variables (F = 13.5-19.9, <i>p</i> < 0.001). Improvements continued at the 8-week follow-up. <b>Conclusions:</b> Patients with DFUs who receive EMF therapy experience a significant improvement in their peripheral microcirculation, tissue perfusion, as well as vascular indices. This is more effective than just mechanical offloading, and custom insoles offer extra benefits by redistributing pressure. Combining EMF therapy with regular DFU care may speed up healing and lower the risk of problems. Additional research should investigate the efficacy of combined EMF as well as off-loading interventions and their long-term outcomes.