Therapeutic ultrasound is a common modality for pain management and rehabilitation therapy which has been clinically utilized for 60 years. Specifically designed ultrasonic devices for accelerated healing and wound site debridement are generally hand-operated bulky systems. As such, they are used on a case-by-case basis with irregular therapeutic treatment regimens dependent on patient access and associated treatment costs. This limits ultrasounds effectiveness and its broad-use in the military/civilian wound healing. Recent innovation and FDA regulatory clearances by ZetrOZ in the development of portable, wearable, long duration, low intensity therapeutic ultrasound systems, allows ultrasound to be delivered and sustained for 4 hours of daily therapeutic treatment. Initial studies have demonstrated that the long duration ultrasound device speeds healing in a small-animal wound model and a pilot study of a chronic wound. Here, we propose to modify the device for optimal use in a wound healing scenario, and conduct initial large-animal studies measuring the ability of the device to facilitate accelerated wound closure and healing. The wounds will be assessed both visually and with histological sections. Following completion of this Phase I study, a Phase II study will expand on these results, and obtain GLP animal data for regulatory filings with FDA.
