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

Materials and Methods

A total of 9 patients with chronic wounds undergoing wound care therapy at a single-center, single-physician clinic were started on UHF-ES therapy after not demonstrating wound healing with standard care.[13] All other patients who did not demonstrate wound healing with standard care were offered, yet declined, the novel therapy. The 9 patients included in this study were treated with UHF-ES irrespective of the wound care regimen at the time and only as an adjunct to the wound treatment previously performed. After each treatment, the wound was measured and dressed according to each patient's individualized protocol. Wound pain levels according to a 10-point visual analog scale (VAS), with 10 being worst, were noted before and after each treatment.

The UHF-ES therapy was performed using the TrueRelief device (TrueRelief). The UHF-ES device, which has received clearance from the US Food and Drug Administration, is a pain-modulating device used in the treatment and alleviation of acute and chronic pain. Unlike other ES devices, the study device delivers electrical current at a UHF of 20 000 Hz. Therapy is provided via 2 stainless steel handheld probes that are held in contact with the patient's body and are directly controlled at the area of treatment by the clinician.

The device settings for each treatment were set to "ultra-high" frequency, carrier "10," and calibration "5." After undergoing wound debridement and cleansing, each patient received the electroceutical treatment at anterior-posterior and medial-lateral aspects of the wound for a total of 10 minutes 3 times weekly. For circular wounds, treatment followed the circumference of the wound, with the probes remaining on opposite sides of the wound.

Pain measurements were obtained by requesting a patient's subjective value relative to VAS. Wound measurements were documented by direct measurement. Finally, patient dermal oxygen perfusion was measured at precise points along the periphery of the wound using a noninvasive near-infrared imaging device (SnapshotNIR; Kent Imaging).