Non‐contact low‐frequency ultrasound therapy compared with UK standard of care for venous leg ulcers: a single‐centre, assessor‐blinded, randomised controlled trial

Abstract

Abstract'Hard-to-heal' wounds are those which fail to heal with standard therapy in an orderly and timely manner and may warrant the use of advanced treatments such as non-contact low-frequency ultrasound (NLFU) therapy. This evaluator-blinded, single-site, randomised controlled trial, compared NLFU in addition to UK standard of care [SOC: (NLFU + SOC)] three times a week, with SOC alone at least once a week. Patients with chronic venous leg ulcers were eligible to participate. All 36 randomised patients completed treatment (17 NLFU + SOC, 19 SOC), and baseline demographics were comparable between groups. NLFU + SOC patients showed a −47% (SD: 38%) change in wound area; SOC, −39% (38%) change; and difference, −7⋅4% [95% confidence intervals (CIs) −33⋅4-18⋅6; P = 0⋅565]. The median number of infections per patient was two in both arms of the study and change in quality of life (QoL) scores was not significant (P = 0⋅490). NLFU + SOC patients reported a substantial mean (SD) reduction in pain score of −14⋅4 (14⋅9) points, SOC patients' pain scores reduced by −5⋅3 (14⋅8); the difference was −9⋅1 (P = 0⋅078). Results demonstrated the importance of high-quality wound care. Outcome measures favoured NLFU + SOC over SOC, but the differences were not statistically significant. A larger sample size and longer follow-up may reveal NLFU-related improvements not identified in this study.

Does noncontact low‐frequency ultrasound therapy contribute to wound healing at the molecular level?

“…CVLUs epitomize a dreaded complication of chronic venous disease including superficial and deep venous hypertension, reflux, and insufficiency. Patients with CVLUs have a substantially poorer QoL due to the associated pain, odor, and reduced mobility . The onset of infection may further delay the healing process in such lesions .…”

“…Noncontact low‐frequency ultrasound (NLFU) has been used to treat various types of chronic wounds including diabetic and pressure ulcers as well as venous leg ulcers . The NLFU system uses continuous ultrasonic energy to atomize saline and deliver continuous energy to the treatment site.…”

Effective biofilm removal and changes in bacterial biofilm building capacity after wound debridement with low-frequency ultrasound as part of wound bed preparation before skin grafting

“…24 Experience derived from daily clinical practice of wound therapy has shown that removal of necrotic or devitalized tissue is perhaps the most important part of local wound treatment and minimizes the bioburden of wounds by decreasing the presence of bacteria, reducing the hypoxic part of the wound, and diminishing the local inflammatory reaction. 17 Extensive and detailed wound assessment at patient's admission is a prerequisite for determining appropriate treatment pathway to be followed.…”

Current perspectives on therapeutic ultrasound in the management of chronic wounds: a review of evidence

“…[47][48][49][50][51][52][53][54][55][56][57] Six of the studies were randomized controlled trials, 47,50,52,54,55,57 two studies were placebocontrolled (mock intervention used) trials, 48,49 one study was a retrospective analysis/case series, 53 one study was a comparative analysis 54 and one study was a non-comparative analysis. 51 Four studies examined venous ulcers, 49,[55][56][57] five studies examined chronic leg ulcers 47,48,51,53 with one study that included individuals that also had critical limb ischemia, 52 one study examined DFUs 50 and one study examined pressure ulcers. 54 Only two studies 47,48 reported no significant differences in any measured dependent variable.…”

“…White et al 57 in a single-site, evaluator-blinded randomized control trial SOC therapy delivered at least once weakly with NCLFU plus SOC therapy on change in wound area, quality of life (QoL) scores, pain scores and infection numbers. Wound area decreased by 47% in the SOC-NCLFU treatment group versus 39% reduction in the SOC therapyonly treatment group.…”