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

November 19, 2023 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: We-Yu Kang, University
  • Phone Number: 575051 05-5330002
  • Email: Y01424@ylh.gov.tw

Study Locations

  • Taiwan
      • Huwei, Taiwan, 632
        • National Taiwan University Hospital Yunlin Branch hemodialysis room
      • Huwei, Taiwan
        • National Taiwan University Hospital Yunlin Branch hemodialysis room

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: far-infrared radiation on foot acupoints
experimental group far-infrared radiation on foot acupoints during dialysis,during dialysis,, and the irradiation distance was 20 cm for 40 minutes each time for six months.
Device: far-infrared radiation
far-infrared radiation on foot acupoints (Yinlingquan and Sanyinjiao acupoints) during dialysis
No Intervention: The control group received general clinical routine care
no far-infrared radiation on foot acupoints

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: intervention 1,2,3 and 6 month change is being assessed
investigators :receiving far-infrared intervention;participants :general clinical care
intervention 1,2,3 and 6 month change is being assessed

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of basic data and disease characteristics distribution between the two groups
Time Frame: two groups before receiving far-infrared intervention (month 0)"change" is being assessed
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
To compare the "Edinburgh claudication questionnaire" and "ABI" before (month 0) receiving far-infrared lower extremity acupoint irradiation therapy and general clinical care
Time Frame: two groups before receiving far-infrared intervention (month 0)"change" is being assessed,
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,

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202212028DINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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