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A Prospective Comparative Study on the Additive Effect of Neuromuscular Electrical Stimulation Rehabilitation on LDL Apheresis Therapy in Patients with Chronic Limb-Threatening Ischemia

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Chronic Limb-Threatening Ischemia (CLTI)
Date of first enrollment	01/08/2025
Target sample size	14
Countries of recruitment
Study type	Interventional
Intervention(s)	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 times per week NMES Applied before or after LDL apheresis sessions, using 20 Hz for 20 minutes at the maximum tolerable intensity. If 20 Hz is not tolerated, 4 Hz will be used NMES is a non-invasive muscle stimulation therapy aimed at improving muscle strength and blood flow Control Group Patients will receive LDL apheresis alone same schedule and method as the intervention group NMES will not be applied Conventional Exercise Therapy Not routinely performed due to the nature of CLTI However, gradual introduction may be allowed at the discretion of the attending physician depending on ulcer healing and ADL recovery

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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