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

Disclosures

Wounds. 2021;33(5):119-126. 

In This Article

Results

Four weeks into intervention, 1 patient died from complications of a severe comorbidity; however, those data have been included for consideration and calculation as the wound demonstrated an increase in the healing rate per week with the use of the UHF-ES device up until time of death.

Patient information gathered during data collection included patient age and sex as well as etiology, location, and duration of wound (Table 1). Additional wound data included the total weeks of active treatment with the UHF-ES device, change in pain levels as assessed using the VAS scale, percentage of tissue oxygenation change from the start of treatment, the wound size calculated at 8 weeks prior to the initiation of therapy, and final wound dimensions upon termination of treatment with the UHF-ES device (Table 2).

Wound change calculations were performed, including closure in measured surface area in centimeters squared during the 8 weeks prior to initiation of UHF-ES treatment as well as closure demonstrated during treatment (Table 3). The rates of closure were normalized by converting the change in dimensions and each phase to percentages of total wound closure based on the measurement at the beginning and end of each phase. Additionally, because the number of weeks of treatment per patient varied, a final calculation correcting for this difference as rate of closure per week of treatment was performed.

The average treatment time was 7.9 weeks. One patient was insensate and another patient experienced an increase in pain during treatment. Of the 8 patients with sensation, 7 (88%) experienced a decrease in wound pain. During treatment, those 8 patients experienced an average reduction in pain of 3.4 points based on the VAS; the mean level of pain was 4.14 before treatment and 0.71 after. The rates of closure per week before and after treatment were evaluated for statistical significance using two-tailed paired t test in Excel (2007; Microsoft) and were found to be statistically significant (P = .0027). Calculation of the percentage of change as a sum of each patient change with treatment versus without treatment was also statistically significant (P = .001) (Table 4, Table 5). However, the data presented within these parameters were not corrected for change per week; thus, this determination of significance was not used. Calculation of the significance of change in level of pain on VAS was not performed, nor was calculation of the significance of tissue oxygenation saturation performed.

All 9 cases in this report are presented and expanded below.

Case 1

A 70-year-old male with a medical history of stage 3 chronic kidney disease, hypertension, rheumatoid arthritis, and lower extremity edema with venous stasis dermatitis was undergoing treatment for a painful right ankle venous ulceration that had been present since early 2017. Lower extremity vascular studies indicated venous disease without arterial compromise. Wound care treatment included debridement, multilayer compression dressings, and application of biologic skin graft substitutes. The patient subsequently underwent 9 weeks of adjunct UHF-ES treatment to the point of wound closure and reported a decrease in VAS pain score from 3 to 0. The wound had 6.64% closure per week prior to using UHF-ES and 11.11% closure per week with the addition of UHF-ES. The patient experienced complete wound healing (Figure 1).

Figure 1.

Case 1: wound at the (A) initiation and (B) completion of treatment.

Case 2

An 84-year-old male with a history of chronic lymphoid leukemia, severe aortic stenosis, pulmonary hypertension, and peripheral arterial disease (PAD) had been undergoing treatment since September 2019 for a right lower extremity wound sustained in 2016 due to local trauma. The patient was followed by a vascular specialist and underwent endovascular intervention for perfusion optimization prior to this period of observation. Wound care treatment included antimicrobial topical ointments, antimicrobial dressings, moisture control dressings, and wound debridement. The patient died due to complications of the comorbid conditions during the study period. Before death, the patient underwent a total of 4 weeks of UHF-ES treatment, during which time he reported a decrease in VAS pain score from a range of 5 to 7 to a range of 2 to 3. The wound had 3.75% closure per week prior to using UHF-ES and 9.29% closure per week with the addition of UHF-ES (Figure 2).

Figure 2.

Case 2: wound at the (A) initiation and (B) completion of treatment.

Case 3

A 68-year-old male with a medical history of PAD, hypertension, and idiopathic lower extremity neuropathy presented in June 2019 for treatment of a neuropathic right medial heel wound of 5 months' duration. Arterial duplex and tissue perfusion studies demonstrated adequate perfusion for healing. Wound care treatment consisted of antimicrobial alginate dressings, weekly wound debridement, and biologic topical agents. The patient then underwent 9 weeks of adjunct UHF-ES. Pain-related information was not gathered because the wound was insensate. The wound experienced 0% closure per week prior to using UHF-ES and 8.73% closure per week with the addition of UHF-ES. Complete wound healing was achieved (Figure 3).

Figure 3.

Case 3: wound at the (A) initiation and (B) completion of treatment.

Case 4

A 53-year-old female with a medical history of kyphosis and scoliosis had been undergoing wound treatment since June 2017 for a large surgical site wound after complications of spinal surgery closure. The patient underwent continuous wound care, including multiple surgical revisions, attempted closure using a split-thickness skin graft (STSG), serial debridement, and intermittent negative pressure wound therapy several months at a time. Local wound care was performed for 8 weeks prior to using UFH-ES with biologic wound healing topicals and dressing changes done 3 times per week. She then underwent 6 weeks of adjunct UHF-ES. At 6 weeks, the patient willfully withdrew from the adjunct treatment owing to new-onset, intolerable, radiculopathy type pain clinically attributed to the use of UHF-ES. The wound had 1.13% closure per week prior to using UHF-ES and 12.95% closure per week with the addition of UHF-ES (Figure 4).

Figure 4.

Case 4: wound at the (A) initiation and (B) completion of treatment.

Case 5

A 58-year-old male with a medical history of hypercholesterolemia, smoking 10 packs of cigarettes per year, thyroid disorder, and third-degree burns of the entire left lower extremity from childhood presented in November 2019 for evaluation of a recurrent wound to the left thigh that had most recently been present for 2 months. The patient's comorbid conditions were controlled with medications, and palpable pedal and common femoral pulses with brisk capillary fill time (CFT) were noted. The patient was treated with continuous wound care from presentation, including sharp excisional debridement, nonadherent dressings, and silicone bandaging. Then the patient underwent adjunct UHF-ES therapy for 11 weeks. The VAS pain score decreased from 6 to 2. The wound had 4.52% closure per week prior to using UHF-ES and 10.43% closure per week with the addition of UHF-ES (Figure 5).

Figure 5.

Case 5: wound at the (A) initiation and (B) completion of treatment.

Case 6

A 70-year-old male with a medical history of controlled type 2 diabetes, coronary artery disease, hypertension, hypercoagulable state with deep vein thrombosis, decreased right ventricular ejection fraction, and Hodgkin lymphoma underwent 4 years of recurrent therapy for a difficult trauma wound. The patient had palpable pulses and intact protective sensation via monofilament. During this period, glycosylated hemoglobin was 6.9%. Treatment included sharp debridement and application of custom topical antimicrobial cream with routine wound dressing changes. The patient underwent 11 weeks of concomitant UHF-ES treatment. The VAS pain score decreased from 2 to 0. The wound had 4.04% closure per week prior to using UHF-ES and 4.13% closure per week with the addition of UHF-ES (Figure 6).

Figure 6.

Case 6: wound at the (A) initiation and (B) completion of treatment.

Case 7

A 57-year-old female with a medical history of hypothyroidism, hypertension, immunodeficiency secondary to chronic corticosteroid therapy, and pyoderma gangrenosum presented in 2015 for evaluation and treatment of a right anterior leg wound (secondary to insect bites) that had been present since 2002. The patient underwent systemic treatment with human immune globulin and local treatment with topical clobetasol propionate to modulate the autoimmune reaction. The patient demonstrated excellent perfusion with palpable pulses and brisk CFT. The patient had undergone continuous wound care, including repeat autologous STSG and serial applications of biologic skin graft substitutes. During the period of observation, treatment consisted of daily application of custom topical antimicrobial cream and marginal clobetasol with nonadherent dressings. The patient received additional UHF-ES treatment for 11 weeks. The VAS pain score decreased from 6 to 1. The wound had 1.85% closure per week prior to using UHF-ES and 2.67% closure per week with the addition of UHF-ES (Figure 7).

Figure 7.

Case 7: wound at the (A) initiation and (B) completion of treatment.

Case 8

An 87-year-old female with a medical history of squamous cell carcinoma and radiation therapy presented in September 2017 with a painful right distal anterior leg wound secondary to tumor excision and radiation therapy received in May 2017. The patient underwent continuous treatment, including serial sharp debridement, serial biologic skin graft substitutes, hyperbaric oxygen therapy (HBOT), and antimicrobial alginate dressings. During the period of observation, treatment consisted of antimicrobial alginate dressings and light serial debridement. The patient then underwent 8 weeks of UHF-ES in conjunction with the prior treatment. The VAS pain score decreased from 3 to 0. The wound had 0% closure per week prior to using UHF-ES and 6.99% closure per week with the addition of UHF-ES (Figure 8, Figure 9).

Figure 8.

Case 8: wound at the (A) initiation and (B) completion of treatment.

Figure 9.

Case 8: wound tissue oxygenation levels at the (A) initiation and (B) completion of treatment.

Case 9

A 35-year-old male with a medical history of morbid obesity, chronic anticoagulation, and PAD status after lower extremity arterial bypass surgery presented in June 2017 for evaluation and treatment of a chemical burn wound on the dorsal right foot sustained 4 months prior. The patient demonstrated palpable pulses and brisk CFT on extremity examination. Wound care treatment included HBOT, STSG, serial sharp debridement, and topical antimicrobial alginate dressings. During the period of observation treatment consisted of antimicrobial alginate dressings and serial debridement. The patient underwent 8.5 weeks of additional UHF-ES treatment. The VAS pain score decreased from 3 to 0. The wound demonstrated 4.71% closure per week prior to UHF-ES and 7.84% closure per week with the addition of UHF-ES (Figure 10).

Figure 10.

Case 9: wound at the (A) initiation and (B) completion of treatment.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....