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

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 (R)) platform (Tennant Biomodulator((R)) 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 cm(2) vs 4W: 5.8 +/- 8.0 cm(2), 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.

Automated summary

This study aimed to examine the effectiveness of daily home-based electrical stimulation therapy as an adjunctive treatment in speeding up wound healing in patients with chronic diabetic foot ulcers. The findings showed that daily home-based electrical stimulation therapy significantly reduced wound area and patients had high adherence to the therapy.