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Far Infrared Therapy on Peripheral Artery Disease in Hemodialysis Patients

NCT01095549 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2010-05-27

No results posted yet for this study

Summary

The prevalence of peripheral artery disease (PAD) defined as ankle-brachial index (ABI) less than 0.9 was about 15\~30% in patients with end stage renal disease (ESRD), which was higher than those with normal renal function. A lower ABI and a higher brachial-ankle pulse wave velocity (baPWV) are good markers to predict the risk of PAD and atherosclerosis respectively. In addition, baPWV\>2,100 cm/s was shown to be related to potential PAD. ABI \<0.9 was positively associated with vascular access failure in hemodialysis (HD) patients and our previous study has demonstrated that far infrared (FIR) therapy can improve access flow and unassisted patency of atrioventricular (AV) fistula.

The aims of this study are to evaluate (1) the frequency of and (2) risk factors associated with abnormal ABI and PWV as well as (3) the effect of FIR on ABI and PWV and markers related to endothelial dysfunction in HD patients.

Conditions

Interventions

DEVICE

WSTM TY101 FIR emitter (Far infrared therapy)

A WSTM TY101 FIR emitter (WS Far Infrared Medical Technology Co., Ltd., Taipei, Taiwan) will be used for FIR therapy. The electrified ceramic plates of this emitter generate electromagnetic waves with wavelengths in the range between 3 and 25 μm (a peak between 5 to 6 μm). The irradiating power density is 10 and 20 mili watt\<mw\>/cm2 when the top radiator is set at a distance between 30 and 20 cm above the skin surface respectively. In this study, the top radiator will be set at a height of 25 cm above the surface of bilateral lower legs and the treatment time will be set at 40 minutes for patients on each HD section for a year.

DEVICE

Placebo device

A device without far infrared therapy

Sponsors & Collaborators

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Principal Investigators

  • Chih-Ching Lin, MD, PhD · Taipei Veterans General Hospital, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-04-30

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01095549 on ClinicalTrials.gov