Effectiveness of Lower Extremity Electrical Stimulation to Improve Skin Perfusion

While few studies suggest the benefit of electrical stimulation (E-Stim) therapy to accelerate wound healing, the underlying mechanism of action is still debated (1-3). In this study, we examined the potential effectiveness of lower extremity E-Stim therapy to improve tissue perfusion in patients with diabetic foot ulcers (DFUs).

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) were recruited. Participants underwent 60-minutes of active E-Stim therapy provided at the level of the ankle joint using a bio-electric stimulation technology (BESTTM) platform*. Changes in perfusion in response to E-Stim were assessed by measuring skin perfusion pressure (SPP), at baseline, 30-, 60-, and 10-minutes post-therapy. A subgroup of patients with moderate-severe peripheral arterial disease (ankle brachial index of < 0.8 or >1.4) was additionally assessed with a near infrared camera† to detect tissue oxygen saturation (SatO2). Generalized linear model was used for analysis. The study was registered in Clinicaltrials.gov-Identifier: NCT03821675.

SPP increased in response to E-Stim therapy with time (p=0.02). Maximum level of improvement was seen after 60-min (11% higher, p=0.007), which immediately reduced after 10-min post-therapy (9% higher, p=0.1) compared to baseline. The subgroup showed a baseline SatO2 below 75% for all patients which significantly increased after 30-min (13.1% higher, p=0.03) and 60-min (12.9% higher, p=0.02), compared to baseline. SatO2 was also significantly increased at 60-min compared to retention (p=0.003). Magnitude of improvement at 60-min was significantly negative correlated with baseline SPP (r=-0.45, p=0.01) and SatO2 (subgroup) (r=-0.79, p < 0.001) values, suggesting those with lower perfusion could benefit more from E-Stim therapy.

This study provides early results on the feasibility and effectiveness of E-Stim therapy to improve skin perfusion and address lower foot perfusion in patients with DFUs. Results also suggest the effects of E-Stim could be washed out after stopping therapy and thus regular daily application may be required for the effective benefit for wound healing.

Trademarked Items (if applicable): * Bio-electric stimulation technology (BEST™) platform, Tennant Biomodulator PRO®, AVAZZIA, Inc., DAL, TX, US
† Snapshot NIR, KENT Imaging Inc., Calgary, AB, CAN

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
Plantar Sensation Among Patients With Diabetic Peripheral Neuropathy: A Randomized Double Blinded Study. J Diabetes Sci Technol.
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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.