title: 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: '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.
authors.affiliation: Cedar, Cardiff and Vale University Health Board, Cardiff Medicentre, Cardiff, UK. judith.white3@wales.nhs.uk.
authors.forename: Judith
authors.initials: J
authors.lastname: White
authors.affiliation: Wound Healing Research Unit, Cardiff University, School of Medicine, Cardiff, UK.
authors.forename: Nicola
authors.initials: N
authors.lastname: Ivins
authors.affiliation: Cedar, Cardiff and Vale University Health Board, Cardiff Medicentre, Cardiff, UK.
authors.forename: Antony
authors.initials: A
authors.lastname: Wilkes
authors.affiliation: Cedar, Cardiff and Vale University Health Board, Cardiff Medicentre, Cardiff, UK.
authors.forename: Grace
authors.initials: G
authors.lastname: Carolan-Rees
authors.affiliation: Wound Healing Research Unit, Cardiff University, School of Medicine, Cardiff, UK.
authors.forename: Keith G
authors.initials: KG
authors.lastname: Harding
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D007871:Leg Ulcer / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D014464:Ultrasonic Therapy; D006113:United Kingdom; D014647:Varicose Ulcer / Q000628:therapy*; D014945:Wound Healing / Q000502:physiology*
keywords: Compression; Quality of life; Ultrasound therapy; Venous leg ulcers; Wound healing