title: Effect of a Low-Intensity Pulsed Ultrasound Device, SX-1001, on Clinical Symptoms in Buerger Disease With Limb Ischemia.
abstract: Buerger disease is a rare disease of unknown etiology and cannot be treated by bypass surgery or percutaneous re-endovascularization. Although the need for effective limb ischemia prevention strategies is increasingly being recognized, effective preventative strategies are insufficient. The aim of this study using a new pulsed ultrasound device, SX-1001, is to determine whether treatment using SX-1001 can mitigate rest pain and improve blood supply to ischemic legs in patients with Buerger disease. This study is a multicenter, double-blinded, parallel randomized clinical trial testing the efficacy and safety of SX-1001. Treatment using SX-1001 is expected to result in reduction of the visual analog scale score for pain in Buerger disease patients who have Fontaine stage III. A total of 44 patients from 20 hospitals in Japan will be enrolled. The primary endpoint of the trial is a change in rest pain intensity on the visual analog scale score from baseline to 24 weeks. This trial will be the first to show the safety and efficacy of low-intensity pulsed ultrasound using SX-1001 for clinical symptoms in patients with Buerger disease. Low-intensity pulsed ultrasound may be a new therapy for limb ischemia. Ethical approval has been obtained from each of the participating institutes. Study findings will be disseminated through peer-reviewed journals and at scientific conferences.This study is registered at UMIN Clinical Trial Registry (UMIN000014757).
authors.affiliation: Department of Cardiovascular Regeneration and Medicine, Research Institute for Radiation Biology and Medicine, Hiroshima University.
authors.forename: Yukihito
authors.initials: Y
authors.lastname: Higashi
authors.forename: Nobuyoshi
authors.initials: N
authors.lastname: Azuma
authors.forename: Yasuchika
authors.initials: Y
authors.lastname: Takeishi
authors.forename: Tohru
authors.initials: T
authors.lastname: Minamino
authors.forename: Yasuki
authors.initials: Y
authors.lastname: Kihara
authors.forename: Koichi
authors.initials: K
authors.lastname: Node
authors.forename: Masataka
authors.initials: M
authors.lastname: Sata
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Fukumoto
authors.forename: Hideki
authors.initials: H
authors.lastname: Origasa
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Matsuo
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Naritomi
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Fujita
authors.forename: Wataru
authors.initials: W
authors.lastname: Shimizu
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005121:Extremities / Q000098:blood supply*; D005260:Female; D006801:Humans; D007511:Ischemia / Q000209:etiology / Q000628:therapy; D008297:Male; D008875:Middle Aged; D059408:Pain Management / Q000379:methods; D010147:Pain Measurement; D013919:Thromboangiitis Obliterans / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy; D016896:Treatment Outcome; D014464:Ultrasonic Therapy / Q000009:adverse effects / Q000379:methods; D000069453:Ultrasonic Waves; D016138:Walking