Clinical trial to establish optimal exercise therapy using near infrared spectroscopy(NIRS) to monitor Skeletal Muscle Oxygen Saturation(StO2) in patients with chronic limb ischemia

Not Applicable

Recruiting

• Conditions: Chronic limb ischemia

• Registration Number: JPRN-UMIN000035288
• Lead Sponsor: Kyoto Prefectural University of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-01
• Study Completion: 2023-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

1) Even if the disease or the surgical procedure is appropriate, informed consent can not be obtained from the patient, or patient's family need emotional consideration and it is difficult to adapt 2) Patients with life expectancy likely to be within one year due to complications 3) The untreated limb is Fontaine Classification III or more 4) Patient with active cancer treatment 5) Patient with ischemic heart disease who are not performed revascularization 6) Patients with untreated severe diabetic retinopathy 7) Patients with sever infection 8) Patients with significant liver impairment, significant renal impairment (except chronic maintenance dialysis) 9) Severe hematological disorder such as leucopenia and thrombocytopenia, and severe anemia requiring blood transfusions 10) Women who are pregnant or may be pregnant or lactating 11) Patients who have other severe acute / chronic medical / mental conditions or clinical laboratory test abnormalities, and there is a possibility that the risk may increase due to participation in the present study, or there is a possibility that it may affect interpretation of the result 12) Patients who can not be performed exercise therapy sufficiently due to cerebrovascular disease, bone nerve disease, lower limb amputation 13) Patients who the investigator or subinvestigator judged ineligible for the present study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of changes in maximum walking distance 6 months after revascularization treatment from registration.