The efficacy of combined ultrasound and electric field stimulation therapy in the treatment of venous leg ulcers.

Abstract

Introduction: Venous leg ulcers are the most common cause of leg ulcers. The aim of this study is to assess the effect of Combined Ultrasound and Electric Field Stimulation therapies (CUSEFS) on wound surface area and pain level in patients with venous leg ulcers, utilizing a novel device (BRH-A2 from BRH Medical, Ltd).

Methods: This prospective case series study, conducted by the Department of Plastic Surgery at the Yitzhak Shamir Medical Center, Israel, collected data for subjects treated with CUSEFS with the BRH-A2 device, between April 2018 and September 2019. Measurements of wound area and assessment of pain intensity using a 10-point visual analog score were recorded. At the end of the four-week period, average wound area and pain scores were included for analysis.

Results: Ten consecutive patients met the inclusion criteria. During the study period, all patients exhibited a reduction in the wound surface area. The final average wound surface area was reduced by 53.52% following the combined treatment. Eight out of the ten patients (80%) reported a reduction in pain, with an average pain level reduction of 64% throughout eight consecutive treatments.

Conclusion: CUSEFS therapies with BRH-A2 technology is a promising treatment for venous leg ulcers. In accordance with our preliminary results, this treatment modality can aid in the reduction of wound surface area as well as reducing the pain suffered by patients from these chronic wounds. Larger multicenter studies are needed to further quantify and qualify the beneficial effect of CUSEFS in venous leg ulcers and other chronic wounds.

Lay summary: Venous leg ulcers (VLUs) are painful wounds occurring between the knee and ankle joint, that fail to heal for a period of at least two weeks and occur in the presence of venous disease. VLUs, are the most common cause of leg ulcers, affecting approximately 5% of the general population over the age of 65. Numerous non-invasive treatment modalities have been attempted for healing chronic wounds and ulceration, however, in some instances surgery, although invasive, is the preferred option. For many years, ultrasound (US) has been used therapeutically to treat chronic ulcers. US produces biophysical effects that are significantly beneficial to the wound healing process. Electrical stimulation therapy is another treatment option which contributes to wound healing by influencing the electrochemical wound process.Combined Modulated Ultrasound and Electric Field Stimulation (CUSEFS) have been shown to improve the healing of chronic wounds. However, research has focused predominantly on objective measures of healing, while less consideration has been given to researching the subjective discomfort and the negative impact that ulceration places on the patient. The aim of this study was to assess objective and subjective factors by measuring the short-term effect of CUSEFS on the surface area of wound and on pain levels in patients with venous leg ulcers (VLUs). Our study findings demonstrate that the combined treatment was effective in initiating wound healing and reducing levels of pain in chronic, stagnant, recalcitrant venous leg ulcers.