Transcutaneous Laser Therapy in Chronic Kidney Disease
ConditionChronic Kidney Disease(CKD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Cheng-Kung University Hospital
About this trial
Chronic kidney disease (CKD) affects approximately 10% of the global population, totaling over 800 million people. In Taiwan, one in eight individuals is diagnosed with CKD. According to National Health Insurance data, acute kidney injury and CKD rank first in medical expenditures, imposing a significant burden on patients' quality of life and the national healthcare system. Early intervention in CKD, especially for high-risk populations (e.g., individuals with diabetes or early-stage kidney dysfunction), can slow disease progression, delay the onset of kidney failure, and postpone the need for dialysis.
Transcutaneous venous laser therapy is a non-invasive treatment. Current literature has demonstrated that it enhances blood circulation, alters blood and erythrocyte activity, and exhibits immunomodulatory, anti-inflammatory, and vasodilatory effects on the blood. Additionally, it boosts mitochondrial activity, which is crucial as mitochondria act as the energy powerhouses of cells, providing the necessary energy for kidneys to maintain normal function.
This project aims to investigate whether this non-invasive transcutaneous venous laser therapy can reduce inflammation, improve physical activity, and further enhance patients' quality of life. It also seeks to reduce patients' medical expenses and National Health Insurance costs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals aged >20 years diagnosed with chronic kidney disease (CKD) stages 2-5.
Estimated glomerular filtration rate (eGFR) < 90 ml/min/1.73m² (lasting for more than three months).
Willing to provide routine blood test results before, during, and after each phase of the study.
Disqualifiers
Acute kidney changes within the past three months (e.g., >30% decline in eGFR), or individuals with impaired consciousness, shortness of breath, or inability to follow instructions.
Blood pressure exceeding 160 mmHg at the time of participation.
Severe cardiovascular diseases (e.g., pacemaker implantation), upper limb trauma or infections, systemic lupus erythematosus, or skin cancer.
Use of photosensitizing medications, pregnancy, or malignant tumors.
Trial design
Design model
Crossover
Treatments tested in this trial
Laser
Device60-minute 635 nm red laser intervention 3 times per week for 8 weeks
Red Light
Device60-minute red light sham intervention three times per week for 8 weeks
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Laser first then shamOther 2 interventions
Group B: Sham first then laserOther 2 interventions
Trial outcomes
Primary outcomes
1
Basic data
Participant demographic data and relevant medical histories will be collected, including gender, age, medication usage, chronic diseases, major illnesses, and surgical history.
Time frame
laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks2
Weight
The participant's body weight is measured in kilograms (kg) using a calibrated digital. The measurement is taken with the participant standing upright, wearing light clothing and no shoes to ensure accuracy.
Time frame
laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks3
Height
The participant's height is measured in centimeters (cm) using a stadiometer or a height-measuring rod. The measurement is taken with the participant standing upright, feet together, heels against the wall or stadiometer, and head in the Frankfort horizontal plane. The participant should be barefoot and maintain a natural posture.
Time frame
laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks4
Body Mass Index
Body Mass Index (BMI) is measured by first recording the participant's weight in kilograms (kg) using a calibrated scale while they are barefoot and wearing light clothing. Height is then measured in meters (m) using a stadiometer, with the participant standing upright, feet together. BMI is calculated using the formula BMI = weight (kg) / height (m)².
Time frame
laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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