Low-Intensity Pulsed Ultrasound in Patients With Atherosclerotic Peripheral Arterial Disease: A Pilot Study and Randomized Double-Blind Placebo-Controlled Trial

Introduction Low-intensity pulsed ultrasound (LIPUS) influences myogenesis, osteogenesis, and angiogenesis. The purpose of this study was to evaluate the effect of LIPUS on symptoms in patients with atherosclerotic peripheral arterial disease (PAD). Methods This pilot study was a double-blinded, placebo-controlled, and randomized study for investigation of LIPUS treatment in patients with atherosclerotic PAD. Thirteen subjects received active LIPUS devices, and another 13 control subjects received inactive LIPUS devices for a 24-week period. The outcomes of symptoms, along with visual analog score (VAS), ankle-brachial index (ABI), transcutaneous oxygen pressure (TcPO₂), and skin perfusion pressure (SPP), were evaluated. Investigations of the number and migration of circulating progenitor cells (CPCs) were also performed. Results There was significant decrease in rest pain intensity on VAS after 24-week LIPUS treatment. During the 24-week period, LIPUS treatment had a tendency to increase ABI and TcPO₂. There was no significant increase in SPP. No significant changes in ABI, TcPO₂, SPP, and VAS in the control group was found. The number of and migration of CPCs were increased in patients with atherosclerotic PAD after LIPUS treatment. No severe adverse effects were observed in any of the patients who underwent LIPUS treatment. Conclusions LIPUS is a safe and non-invasive treatment, and it improves symptoms in patients with atherosclerotic PAD. Through ultrasound irradiation, inferences in therapeutic cellular regeneration, patients with chronic limb ischemia, including non-atherosclerotic PAD, of different severity levels can benefit from LIPUS.