Patients with critical limb ischemia critical limb ischemia
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| adverse event | — |
Secondary
| Measure | Time 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
Hiroshima University Hospital