Safety and Effectiveness of a Low-Intensity Pulsed Ultrasound Device on Clinical Symptoms in Patients with Critical Limb Ischemia.

JRCT ID: jRCTs062200008

Registered date:02/07/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with critical limb ischemia
• Date of first enrollment: 02/07/2020
• Target sample size: 100
• Study type: Interventional

Intervention(s)

The ultrasound irradiation was applied over the skin of
the ischemic area of the thigh region for 20 minutes per day

Outcome(s)

• Primary Outcome: adverse event
• Secondary Outcome: Changes in Visual analog scale, macroscopic findings of ulcer, Walking impairement questionnaire, ankle brachial pressure index, skin perfusion pressure, transcutaneous oxygen tension, flow-mediated vasodilation, major amputation-free survival rates, duration until major amputation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(a) 20 years of age or more
(b) Patients with atherosclerotic peripheral arterial disease or Buerger disease or vasculitides secondary to connective tissue diseases
(c) Patients with critical limb ischemia who are at risk of major amputation if they do not receive specific treatment
(d) Patients gave written informed consent for participation in the study

Exclude criteria

(a) A history of malignant disease within five years prior to the study
(b) A history of myocardial infarction or cerebrovascular disease within three months prior to the study
(c) pregnancy or possible pregnancy
(d) Patients can not use LIPUS due to impaired cognitive function or physical function
(e) Inappropriate to enter this trial judged by physician

Related Information

• Primary Sponsor: Higashi Yukihito