Clinical Effects of Weekly and Biweekly Low-Frequency Ultrasound Debridement Versus Standard of Wound Care in Patients with Diabetic Foot Ulcers: A Pilot Randomized Clinical Trial

The aim of this study was to evaluate clinical effects of weekly (UD/week) and biweekly (UD/2-weeks) low-frequency ultrasound debridement (UD) on wound healing, healing time, wound area, granulation tissue, and transcutaneous oxygen pressure (TcPO₂) in patients with diabetic foot ulcers (DFUs), compared to the standard of care (SoC). A pilot randomized clinical trial was conducted involving 30 patients with DFUs who received either UD/week (n = 10), UD/2-weeks (n = 11), or SoC (n = 9) every week over a 12-week treatment period. Healing rates at 6 months were 70% in the UD/week, 54.4% in the UD/2-weeks, and 33.3% in the SoC (<i>P</i> = .27). The healing times were 11 (IQR 7-19) weeks for UD/week, 18 (IQR 15-36) weeks for the SoC, and 24.5 (IQR 16-30) weeks for the UD/2-weeks group (<i>P</i> = .036). Wound area was reduced by 87.5 ± 18.5% in the UD/week, 68.6 ± 26.2% in the UD/2-weeks, and 38.9 ± 16.6% in the SoC (<i>P</i> = .014). Wollina wound scores were 7 (IQR 6-7) in the UD/week, 7 (IQR 6.5-7) in the UD/2-weeks, and 4 (IQR 3-6) in the SoC (<i>P</i> = .002). UD/week showed not significantly higher healing rates than the UD/2-weeks and SoC, but experienced significantly shorter healing time, a greater percentage of wound area reduction and higher Wollina wound score. These findings suggest that UD/week could be a valuable therapeutic option in clinical practice, particularly for patients in whom sharp debridement is not a viable option or who require an alternative approach to promote wound healing. This study is registered in ClinicalTrial.gov.