To Investigate the Effect of Far-infrared Radiation on Lower Extremity Acupoints on the Blood Circulation of Lower Extremities in Patients With Hemodialysis

Peripheral Arterial Disease Clinical Trial

Official title:

To Investigate the Effect of Far-infrared Radiation on Lower Extremity Acupoints on the Blood Circulation of Lower Extremities in Patients With Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05822960
• Other study ID #: 202212028DINA
• Status: Completed
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: August 10, 2023

Study information

• Verified date: February 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study intends to irradiate the acupoints of both lower extremities of hemodialysis patients with far-infrared therapeutic apparatus to explore its effect on foot blood circulation, peripheral artery occlusion disease (PAOD) symptoms and ankle-brachial index (Ankle-Brachial Index, ABI) value.

Description:

After irradiating the lower extremity acupoints of hemodialysis patients with far-infrared rays, it is expected to improve the blood circulation of the lower extremities of hemodialysis patients, thereby improving the symptoms of indirect claudication and raising the ankle-brachial index to the normal range, and reducing the incidence of peripheral arterial disease in hemodialysis patients. The results of this study can provide an empirical reference for future clinical care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 10, 2023
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

Inclusion Criteria:

• 1.Patients diagnosed with chronic renal failure in a hemodialysis unit and receiving hemodialysis for at least three months 2. Willing to participate in interventional treatment with far-infrared radiation 3. Willingness to cooperate with intervention measures and inspection time 4. Receive hemodialysis treatment three times a week

Exclusion Criteria:

1. There are contraindications for ABI examination (such as breast cancer lymph node dissection in the past), bilateral upper limb arteriovenous access, etc.), and a double- lumen dialysis venous catheter is placed in the groin

2. Bedridden or unable to walk

3. History of distal amputation, DVT, CABG s/p due to trauma, ischemia or infection

4. Consciously unclear and unable to cooperate

5. Patients with wounds from calf to instep

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• far-infrared radiation
far-infrared radiation on foot acupoints (Yinlingquan and Sanyinjiao acupoints) during dialysis

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Yunlin Branch hemodialysis room	Huwei
Taiwan	National Taiwan University Hospital Yunlin Branch hemodialysis room	Huwei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the "Edinburgh Claudication Questionnaire" and "ABI" after receiving far-infrared lower extremity acupoint irradiation therapy (investigators ) and general clinical care (participants) change assessed	investigators :receiving far-infrared intervention;participants :general clinical care	intervention 1,2,3 and 6 month change is being assessed
Secondary	Comparison of basic data and disease characteristics distribution between the two groups	Demographic characteristics include: gender(boy or gril), age, education level, smoking history, presence/absence of exercise, and drinking; disease characteristics include(yes or no): years of dialysis(year), presence/absence of anticoagulant drugs(yes or no); disease history(yes or no): diabetes, hypertension, coronary artery disease disease, cerebrovascular disease The monthly routine inspection items in the hemodialysis room are designed,	two groups before receiving far-infrared intervention (month 0)"change" is being assessed
Secondary	To compare the "Edinburgh claudication questionnaire" and "ABI" before (month 0) receiving far-infrared lower extremity acupoint irradiation therapy and general clinical care	In this study, used the Chinese version of the "Edinburgh Claudication Questionnaire" as a screening test for "intermittent claudication symptoms"; This study intends to use ABI-type equipment for measurement. Because hemodialysis patients have the limitation that the arm on the side of the arteriovenous fistula can not measure blood pressure, the modification is as follows Calculation method: ABI of left foot = systolic pressure of left posterior tibia ÷ systolic pressure of brachial artery without arteriovenous fistula;ABI of right foot is also calculated in the same way	two groups before receiving far-infrared intervention (month 0)"change" is being assessed,