NCT05822960

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2023

Completed
Last Updated

November 22, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

March 6, 2023

Last Update Submit

November 19, 2023

Conditions

Peripheral Arterial Disease

Keywords

hemodialysisperipheral arterial occlusion diseasefar-infrared radiationlower extremity acupointsankle-brachial indexEdinburgh claudication questionnair

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Comparison of basic data and disease characteristics distribution between the two groups

    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

    two groups before receiving far-infrared intervention (month 0)"change" is being assessed,

Study Arms (2)

far-infrared radiation on foot acupoints

EXPERIMENTAL

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

The control group received general clinical routine care

NO INTERVENTION

no far-infrared radiation on foot acupoints

Interventions

far-infrared radiationDEVICE

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

far-infrared radiation on foot acupoints

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Bedridden or unable to walk
  • History of distal amputation, DVT, CABG s/p due to trauma, ischemia or infection
  • Consciously unclear and unable to cooperate
  • Patients with wounds from calf to instep

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Taiwan University Hospital Yunlin Branch hemodialysis room

Huwei, 632, Taiwan

Location

National Taiwan University Hospital Yunlin Branch hemodialysis room

Huwei, Taiwan

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The dialysis day was W 1.3.5 as the control group and W 2.4.6 as the experimental group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2023

First Posted

April 21, 2023

Study Start

February 20, 2023

Primary Completion

August 10, 2023

Study Completion

August 10, 2023

Last Updated

November 22, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(2)