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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062200008
Enrollment
100
Registered
2020-07-02
Start date
2020-07-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with critical limb ischemia critical limb ischemia

Interventions

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

Sponsors

Higashi Yukihito
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
adverse event

Secondary

MeasureTime frame
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

Contacts

Public ContactMasato Kajikawa

Hiroshima University Hospital

m-kajikawa@hiroshima-u.ac.jp+81-82-257-5831

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026