Transcutaneous Laser Therapy in Chronic Kidney Disease

NCT ID: NCT06855992

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-17
• Study Completion Date: 2026-01-31

Brief Summary

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.

Conditions

Chronic Kidney Disease(CKD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Laser first then sham

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.

Group Type: OTHER

Laser

Intervention Type: DEVICE

60-minute 635 nm red laser intervention 3 times per week for 8 weeks

Red Light

Intervention Type: DEVICE

60-minute red light sham intervention three times per week for 8 weeks

Sham first then laser

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.

Group Type: OTHER

Laser

Intervention Type: DEVICE

60-minute 635 nm red laser intervention 3 times per week for 8 weeks

Red Light

Intervention Type: DEVICE

60-minute red light sham intervention three times per week for 8 weeks

Interventions

Laser

60-minute 635 nm red laser intervention 3 times per week for 8 weeks

Intervention Type: DEVICE

Red Light

60-minute red light sham intervention three times per week for 8 weeks

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cheng-Feng Lin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheng-Feng Lin Professor, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cheng-Kung University Hospital

Chien-Yao Sun MD

Role: PRINCIPAL_INVESTIGATOR

National Cheng-Kung University Hospital

Wei-Hung Lin MD

Role: PRINCIPAL_INVESTIGATOR

National Cheng-Kung University Hospital

Li-Chieh Kuo Professor, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cheng Kung University

Central Contacts

Cheng Feng Lin, PhD

Role: CONTACT

connie@mail.ncku.edu.tw

+886-6-2353535 ext. 5721

Other Identifiers

B-BR-113-066-T

Identifier Type: -

Identifier Source: org_study_id