NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs062200008

Registered date:02/07/2020

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedPatients with critical limb ischemia
Date of first enrollment02/07/2020
Target sample size100
Countries of recruitmentJapan
Study typeInterventional
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 Outcomeadverse event
Secondary OutcomeChanges 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 maximumNot applicable
GenderBoth
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

Contact

Public contact
Name Masato Kajikawa
Address 1-2-3 Kasumi, Minami-ku, Hiroshima Hiroshima Japan 734-8551
Telephone +81-82-257-5831
E-mail m-kajikawa@hiroshima-u.ac.jp
Affiliation Hiroshima University Hospital
Scientific contact
Name Yukihito Higashi
Address 1-2-3 Kasumi, Minami-ku, Hiroshima Hiroshima Japan 734-8551
Telephone +81-82-257-5831
E-mail yhigashi@hiroshima-u.ac.jp
Affiliation Hiroshima University Hospital