Chronic limb ischemia
Conditions
Interventions
The optimal exercise therapy Fixation exercise therapy is performed from the day after revascularization therapy, and optimal exercise therapy is started on 7th day after the treatment. Optimal exer
Sponsors
Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female patients who aged 20 years or older and under 80 years of age at the time of signed informed consent form 2) Patients Who are scheduled to register for "regenerative therapy using mononuclear cells" or "regenerative therapy using autologous bone marrow mononuclear cells" under the act on the safety of regenerative medicine 3) Patients with Chronic limb ischemia whose Rutherford Classification is 4 or 5 4) Patient with measurable using NIRS at a designated site. 5) Patients who signed document consent of study participation obtained based on the patient's will and / or families' understanding and consent after receiving sufficient explanation about advantage/disadvantage arising from performing exercise therapy and advantage/disadvantage arising from not performing exercise therapy
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of changes in maximum walking distance 6 months after revascularization treatment from registration. | — |
Countries
Japan
Contacts
Public ContactKenji Yanishi
Kyoto Prefectural University of Medicine Department of Cardiovascular Medicine
Outcome results
None listed