Transcutaneous Laser Therapy in Chronic Kidney Disease (Laser_CKD)

National Cheng-Kung University

Status: Not yet enrolling

Conditions: Chronic Kidney Disease(CKD)

Treatments: Device: Laser; Device: Red Light

Study type: Interventional

Funder types: Other

Identifiers

NCT06855992

B-BR-113-066-T

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Sensory nerve abnormalities, coagulation disorders, or the presence of kidney stones.
• Individuals with a hierarchical relationship to the study's principal investigator or team members (e.g., those from the same laboratory or having a student-mentor relationship).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

120 participants in 2 patient groups

Laser first then sham

Other group

Description:

Administer a 60-minute, 635 nm laser intervention three times per week for 8 weeks, followed by a 6-week washout period. Subsequently, provide a 60-minute red light sham intervention three times per week for another 8 weeks.

Treatment:

Device: Red Light

Device: Laser

Sham first then laser

Other group

Description:

Administer a 60-minute red light sham intervention three times per week for 8 weeks, followed by a 6-week washout period. Subsequently, provide a 60-minute, 635 nm laser intervention three times per week for another 8 weeks.

Treatment:

Device: Red Light

Device: Laser