Home-Based Electrical Stimulation to Accelerate Wound Healing—A Double-Blinded Randomized Control Trial

Abstract

Background: Electrical stimulation (E-Stim) may offer a unique adjunctive treatment to heal complicated diabetic foot ulcers (DFU). Our primary goal is to examine the effectiveness of daily home-based E-Stim therapy to speed-up wound healing. Methods: Patients with chronic DFUs and mild to severe peripheral arterial disease (PAD) were recruited and randomized to either control (CG) or intervention (IG) groups. The IG received 1-hour home-based E-Stim therapy on daily basis for 4 weeks (4W). E-Stim was delivered through electrical pads placed above the ankle joint using a bio-electric stimulation technology (BEST®) platform (Tennant Biomodulator® PRO). The CG was provided with an identical but non-functional device for the same period. The primary outcome included wound area reduction at 4W from baseline (BL). Results: Thirty-eight patients were recruited and 5 were removed due to non-compliance or infection, leaving 33 participants (IG, n = 16; CG, n =17). At 4W, the IG showed a significant wound area reduction of 22% (BL: 7.4 ± 8.5 cm2 vs 4W: 5.8 ± 8.0 cm2, P = 0.002). Average of wound area was unchanged in the CG ( P = 0.982). The self-report adherence to daily home-therapy was 93.9%. Conclusions: Daily home-based E-Stim provides early results on the feasibility, acceptability, and effectiveness of E-Stim as an adjunctive therapy to speed up wound healings in patients with chronic DFU and mild to severe PAD.

Safety and efficacy of electrical stimulation for lower-extremity muscle weakness in intensive care unit 2019 Novel Coronavirus patients: A phase I double-blinded randomized controlled trial

“…The pulse duration was between 400 and 1400 microseconds (µs), and pulse frequency between 20 and 121 hertz (Hz). These same intensity level and pulse characteristics were shown to be harmless in a previously published clinical trial for lowerextremity ischemic lesions (27). E-Stim was discontinued if the patient presented rapid deterioration [i.e., arterial blood oxygen desaturation < 93% under ventilation assistance, hemodynamic instability, septic shock, thigh extracorporeal membrane oxygenation (ECMO) placement, or generalized gross edema] despite intensive care treatment.…”

The Potential of Electrical Stimulation and Smart Textiles for Patients with Diabetes Mellitus

“…ultrasound) have been published (47). Also, wearable flexible devices facilitating electrostimulation for the healing of foot wounds are at different stages of development and even home-based systems as a supportive therapy to speed up the healing process have been tested (48,49). Furthermore, electrostimulatory systems to improve mobilisation and walking abilities of patients with diabetes following minor amputations have been tested and shown encouraging results (50).…”

“…Based on this, efforts to further improve and optimize the results of electrical stimulation are in progress and promising results on the effectiveness of combination of electrical stimulation with other noninvasive measures (e. g., ultrasound) have been published 47 . Also, wearable flexible devices facilitating electrostimulation for the healing of foot wounds are at different stages of development and even home-based systems as a supportive therapy to speed up the healing process have been tested 48 49 . Furthermore, electrostimulatory systems to improve mobilization and walking abilities of patients with diabetes following minor amputations have been tested and shown encouraging results 50 .…”

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“…Also, wearable flexible devices facilitating electrostimulation for the healing of foot wounds are at different stages of development and even home-based systems as a supportive therapy to speed up the healing process have been tested [48,49]. Furthermore, electrostimulatory systems to improve mobilization and walking abilities of patients with diabetes following minor amputations have been tested and shown encouraging results [50].…”