Chronic Limb-Threatening Ischemia (CLTI) Chronic Limb-Threatening Ischemia CLTI
Conditions
Interventions
Intervention Group
Patients will receive LDL apheresis single-column method combined with neuromuscular electrical stimulation NMES
LDL apheresis: Performed 10 times or more over 3 months 1 2 t
Lipoprotein Apheresis Low-Density Lipoproteins Apheresis Neuromuscular Electrical Stimulation Electric Stimulation Therapy Chronic Limb-Threatening Ischemia Peripheral Arterial Disease
Sponsors
Shimanaka Yuusuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients diagnosed with chronic limb-threatening ischemia corresponding to Fontaine stage IV, accompanied by ulcers or gangrene. Patients with skin ulcers for whom treatment with single-column LDL apheresis has already been clinically determined. Patients aged 20 years or older. Patients who have received sufficient explanation about the purpose and content of the study and have provided written informed consent. Patients deemed by the physician to be capable of undergoing evaluations and interventions (LDL apheresis and NMES) during the study period.
Exclusion criteria
Exclusion criteria: Patients with Fontaine stage III or lower who do not have ulcers or gangrene Patients deemed unable to continue evaluations or interventions LDL apheresis or NMES during the study period Patients with a pacemaker or implantable cardioverter-defibrillator ICD for whom NMES is contraindicated Patients with musculoskeletal or neurological disorders that significantly affect evaluation e g post-stroke sequelae progressive neurological diseases limb paralysis) Pregnant or breastfeeding women or those planning to become pregnant during the study period Patients currently participating in another interventional study except for observational studies deemed not to interfere with this study Patients for whom measurement of the studys evaluation items is medically or operationally difficult Patients deemed inappropriate for participation by the principal or sub-investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target limb: Less affected or non-affected lower limb Measurement method: Isometric muscle strength measurement device used for both legs Assessment timing: Before intervention (Visit1) Three months after intervention (Visit3, within one week) Indicator: Change from baseline to three months | — |
Secondary
| Measure | Time frame |
|---|---|
| Ankle Brachial Index Skin Perfusion Pressure Blood test parameters HDL cholesterol LDL cholesterol Triglycerides White blood cell count Hematocrit Hemoglobin Platelet count Fibrinogen C reactive protein Grip strength Calf circumference Severity of skin ulcers Wound grading based on WIFI classification Rutherford classification Quality of life assessment Vascular Quality of Life Questionnaire score Clinical events Limb amputation (major and minor) Revascularization procedures Death (all cause and cardiovascular) Hospitalization due to heart failure, myocardial infarction, or stroke Six minute walk distance Only for participants who are able to perform the test | — |
Contacts
Public ContactYuusuke Shimanaka
Dokkyo Medical University Nikko Medical Cente
Outcome results
None listed