chronic limb-threatening ischemia with arteriosclerotic obliterans
Conditions
Sponsors
Matoba Satoaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who are 20 - 84 years old at the time of obtaining written consent, regardless of gender. 2) Arteriosclerosis obliterans. 3) Patients with Clinical Frailty Scale 7 or less. 4) CLTI patients with Rutherford Classification 4-6. 5) Patients who have not undergone EVT within 12 weeks prior to obtaining consent. 6) Patients whose written consent to participate. 1) Patients with ulcer wound healing that has not been achieved or is unlikely to be achieved by EVT or minor amputation. 2) CLTI patients with Rutherford classification 4-6. 3) SPP less than 40 mmHg on the affected limb. 4) Patients with Clinical Frailty Scale 7 or less. However, patients with Rutherford classification 4 do not have to meet the criteria 1) for enrollment.
Exclusion criteria
Exclusion criteria: 1) Even if the disease and the surgical procedure are appropriate, informed consent cannot be obtained from the patient, or emotional consideration is required for the patient's family and it is difficult to adapt. 2) Have an infectious disease requiring systemic treatment or have a fever of 38.0 degrees or higher at the time of provisional registration. 3) Life expectancy is less than one year due to other complications. 4) HbA1c (NGSP) level of 10% or higher on blood biochemistry tests at the time of provisional registration, or diabetic retinopathy with treatment. 5) If the results of blood biochemical tests at the time of provisional registration correspond to any of the following conditions. However, chronic maintenance dialysis patients are excluded. (1) AST: 100 U/L or more (2) ALT: 100 U/L or higher (3)eGFR: less than 15 mL/min/1.73 square meter 6) The applicant has a blood disorder such as aplastic anemia or thrombocytopenia, or the results of blood biochemical tests at the time of provisional registration correspond to the following conditions. (1) White blood cell count: less than 2,000 /microliter (2) Hemoglobin level: less than 7.0 mg/dL (3) Platelet count: less than 50,000 /microliter 7) Pregnant, possibly pregnant, or nursing mothers. 8) Participation in a clinical trial or clinical study of a drug or medical device concurrent with this study or within 30 days prior to inclusion in this study. 9) Has any other serious acute or chronic medical or psychiatric condition or laboratory abnormality for which participation in the study may increase the risk or affect the interpretation of the study results. 10) Other conditions that would make participation in the study inappropriate in the judgment of the investigator or subinvestigator. 11) Patients with bilateral critical ischemic limbs who, at the time of consent, were deemed by the investigator or study investigator to require immediate provision of vascular regeneration therapy for both lower limbs. 1) Patients who, in the judgment of the investigator or subinvestigator, require immediate EVT or amputation. 2) Patients who have already been actual registration in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any furtuer amputation / Endovascular therapy (EVT) free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Visual Analogue Scale (VAS) (2) WIQ Scale (3) SPP/TcPO2 (4) Clinical Frailty Scale (5) Skeletal muscle mass (6) Rutherford classification (7) Area of ulcers (8) ABI (9) Death / Any furtuer amputation / Endovascular therapy (EVT) free survival rate (10) Endovascular therapy (EVT) free survival rate (11) Amputation free survival rate (12) Time to ulcer disappearance | — |
Countries
Japan
Contacts
Public ContactHideo Tsubata
University Hospital Kyoto prefectural university of medicine
Outcome results
None listed