Use of weekly, low dose, high frequency ultrasound for hard to heal venous leg ulcers: the VenUS III randomised controlled trial

摘要: Objective To assess the clinical effectiveness of weekly delivery low dose, high frequency therapeutic ultrasound in conjunction with standard care for hard to heal venous leg ulcers. Design Multicentre, pragmatic, two arm randomised controlled trial. Setting Community and district nurse led services, community ulcer clinics, hospital outpatient clinics 12 urban rural settings (11 United Kingdom one Republic Ireland). Participants 337 patients at least >6 months’ duration or >5 cm2 area an ankle brachial pressure index ≥0.8. Interventions Weekly administration therapy (0.5 W/cm2, 1 MHz, pulsed pattern 1:4) up weeks plus compared alone. Main outcome measures Primary was time healing largest eligible ulcer. Secondary outcomes were proportion healed by months, percentage absolute change size, participants ulcer-free, health related quality life, adverse events. Results The groups showed no significant difference reference (log rank test, P=0.61). After adjustment baseline area, duration, use compression bandaging, study centre, there still evidence a (hazard ratio 0.99 (95% confidence interval 0.70 1.40), P=0.97). median inestimable. There between all ulcers months (72/168 group v 78/169 group, P=0.39 Fisher’s exact test) nor size four treatment (model estimate 0.05 CI –0.09 0.19)). complete P=0.61), 328 days 235 inestimable) 365 (224 ultrasound. rates recurrence (17/31 14/31 care, P=0.68 test). both physical component score 0.69 (–1.79 3.08)) mental –0.93 (–3.30 1.44)), but significantly more events 0.30 (0.01 0.60)). relation 0.64 (0.55 0.75)) 0.59 (0.50 0.71)), larger older taking longer heal. In addition, those centres recruitment had highest rates. Conclusions Low administered during dressing changes addition did not increase rates, affect reduce recurrence. Trial registrationISRCTN21175670 National Research Register N0484162339