Publication Date

1-1-2023

Journal

Journal of Diabetes Science and Technology

DOI

10.1177/19322968211035128

PMID

34328024

PMCID

PMC9846397

PubMedCentral® Posted Date

7-30-2021

PubMedCentral® Full Text Version

Post-print

Published Open-Access

yes

Keywords

diabetic foot ulcer, electrical stimulation, home-based therapy, skin perfusion, tissue oxygenation, wound healing, wearables, amputation, limb salvage, neuromodulation

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.

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