Effectiveness of daily home electrical stimulation as an adjunctive therapy to accelerate wound healing in people with diabetic foot ulcer – A double blinded randomized control trial

Electrical stimulation (E-Stim) may offer a unique treatment option to heal complicated diabetic foot ulcers (DFU) (1-3). However, there is no randomized controlled trial to examine effectiveness of home-based E-Stim therapy to speed-up wound healing. This study intends to fill this gap.

Thirty-eight patients with DFUs (Age: 62.8±12.3 years, BMI= 30.5±7.1 kg/m2, HbA1C=8.1±1.7 mg/dl, wound area=4.6±7 cm2, SPP=73.3±17.44, wound SatO2=70.6±16.7%) were recruited and randomized (ratio:1:1) to either control (CG: n=19) or intervention (IG:, n=19) groups. The IG received 1-hour E-Stim therapy on daily-basis at home for 4-week. E-Stim was provided on the ankle joint using a bio-electric stimulation technology (BEST™) platform*. The CG was provided with an identical but non-functional device for the same period. Participants and care providers were blinded to the group allocation. Primary outcomes were wound area reduction at 4-week and speed of wound-healing defined as average of daily and weekly changes in wound-area over 24 hrs and 4-week. General linear model was used for analysis. The study was registered in Clinicaltrials.gov-Identifier: NCT03821675.

There were no significant differences for baseline demographics and clinical parameters between groups. At 4-week, Time×Group effect on wound area showed a significant size reduction of 18% in favor of the IG (p=0.014). Speed of wound healing in IG was 119% faster (IG=39% v. CG=17%; p=0.23) at 4-week, and 58% faster (IG=1.41% v. CG=0.61%, p=0.25) at 24 hrs, than the CG. The self-report adherence to daily home-therapy was 90% in IG indicating high feasibility and acceptability of therapy.

This study provides early results on the feasibility, acceptability and effectiveness of home-based E-Stim therapy to improve wound healing in patients with DFUs. The use of home-based daily E-Stim might be a practical adjunctive therapy to speed up wound healing for patients with DFUs.

Trademarked Items (if applicable): * bio-electric stimulation technology (BEST™) platform, Tennant Biomodulator PRO®, AVAZZIA, Inc., DAL, TX, US

References (if applicable): 1. Najafi B, Talal TK, Grewal GS, Menzies R, Armstrong DG, Lavery LA. Using Plantar Electrical Stimulation to Improve Postural Balance and
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2. Thakral G, Kim PJ, LaFontaine J, Menzies R, Najafi B, Lavery LA. Electrical stimulation as an adjunctive treatment of painful and sensory
diabetic neuropathy. J Diabetes Sci Technol. 2013;7(5):1202-9. doi: 10.1177/193229681300700510. PubMed PMID: 24124947; PMCID:
PMC3876364.
3. Thakral G, Lafontaine J, Najafi B, Talal TK, Kim P, Lavery LA. Electrical stimulation to accelerate wound healing. Diabet Foot Ankle. 2013;4.
doi: 10.3402/dfa.v4i0.22081. PubMed PMID: 24049559; PMCID: PMC3776323.