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

Phase 2

Recruiting

Conditions: Patients with critical limb ischemia
critical limb ischemia

Registration Number: JPRN-jRCTs062200008

Lead Sponsor: Higashi Yukihito

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

Inclusion 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

Exclusion 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
adverse event

Secondary Outcome Measures

Name	Time	Method
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