Decreasing Pain and Increasing the Rate of Chronic Wound Closure With the Use of a Noninvasive Bioelectronic Medical Device

A Case Series

David Charles Hatch, DPM; Michael Lavor, MD


Wounds. 2021;33(5):119-126. 

In This Article


In recent decades there has been rapid advancement in treatment modalities designed to improve pain control and the rate of wound healing, decrease complications, and facilitate more effective healing strategies. Recent breakthroughs include advanced dressings,[14–16] bandaging,[17] ultrasonic therapy,[18,19] negative pressure wound therapy,[20,21] and HBOT.[22]

Electrical stimulation therapy has demonstrated effective disruption of surface biofilms, inhibiting the growth of various pathogenic bacterial organisms; augmentation of fibroblast function; reduction in the rates of infection; and the imitation of a healthy bioelectrical environment lost in chronic wounds.[23–26]

Several randomized controlled trials have demonstrated significant improvement in the rate of wound healing with various periwound ES modalities. Peters et al[27] demonstrated a significant difference in wound healing (P = .058) with the active treatment of 20 patients with diabetic foot ulcerations using 50-V direct current treatment for 8 hours nightly for 12 weeks vs placebo (20 patients) using identical functioning equipment but no current. Houghton et al[28] reported a 44% reduction in wound area in 16 patients treated with high-voltage pulsed current therapy and a 16% reduction in wound area in 18 patients treated with placebo therapy for 45 minutes 3 times per week for 4 weeks. Salzberg et al[29] demonstrated a healing rate of 14 days in 9 patients treated with ES vs 35 days in 10 patients who underwent placebo therapy to treat pressure ulcers with localized pulsed electromagnetic field therapy (P = .007).

Additional reports outline advanced wound healing with use of topical ES therapy bandages. In 2013, Whitcomb et al[23] demonstrated a statistically significant increase in rates of closure of 38 wounds by adding a topical microcurrent-generating wound dressing device (P = .018). In 2016, Cole[24] reported on the use of a silver-zinc coupled electroceutical dressing to heal wounds in 3 patients within 6 weeks after 2 years of prior failed treatments.

Chronic wound healing is often hampered by decreased tissue oxygenation. There are many reasons for decreased tissue oxygenation, and while intervention (where feasible) is paramount, there are many exogenous factors that may contribute to poor perfusion, including trauma, obesity, immobility, and chronic physiological stress. Prior studies of ES in wound healing have found upregulation of vascular endothelial growth factor.[30,31] Multiple reports demonstrate improved perfusion to wound tissues after the use of ES.[32] This increase is demonstrated in both arterial flow and venous flow and has been most notable in patients with known PAD.[33] The influence of UHF-ES on local microvascular perfusion is beyond the scope of this study; however, 5 of the 9 patients (56%) demonstrated an observed increase of perfusion of periwound tissue.

Pain associated with wound care therapies has been correlated with increased stress reaction, which has been shown to delay healing.[34,35] Use of ES, specifically transcutaneous electrical nerve stimulation (TENS), has been shown to improve acute and chronic pain. However, TENS treatments are time consuming and require the application of small electrodes to provide therapy for approximately 30 minutes at least twice daily.[36]

The aforementioned treatments differ from the present device in the level and type of current received, mechanism of delivery, and use type (multiuse vs single use); it delivers UHF current with a focal wand and is multiuse. The exact mechanism specific to the present device has yet to be elucidated. One hypothesized mechanism is the downregulation of inflammatory cytokines (eg, interleukin-1β, interleukin-6, tumor necrosis factor α) by suppressing a regulatory molecule for these cytokines (eg, high-mobility group box 1), as its release has been observed to correlate with conductive direction of the afferent nerves.[37–39] Further research into this mechanism is ongoing.