Far Infrared Therapy on Peripheral Artery Disease in Hemodialysis Patients

May 25, 2010 updated by: Taipei Veterans General Hospital, Taiwan

Peripheral Artery Disease in Patients on Maintenance Hemodialysis: Risk Factors and the Effect of FIR Therapy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study, 300 HD patients will be enrolled to receive ABI and baPWV and about 90 patients (30% according to the literature review) who have abnormal ABI (<0.9) or baPWV (>2100 cm/sec) will be randomly allocated to FIR group (receiving FIR therapy for 40 minutes thrice weekly) and control group (without FIR therapy). In patients with abnormal ABI or baPWV, the effect of single or one-year treatment of FIR on the following items will be studied: (1) ABI, (2) baPWV and (3) markers related to endothelial dysfunction [including low and high density lipoprotein cholesterol (LDL and HDL), asymmetric dimethylarginine (ADMA), hypersensitive C-reactive protein (hsCRP), matrix metalloproteinase-9 (MMP-9)]. The effect of FIR on PAD or cardiovascular events during one year of follow-up will also be studied.

This study will allow us to identify the frequency of and the risk factors associated with abnormal ABI & PWV as well as the effect of single or one-year FIR therapy on ABI & PWV in HD patients.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital
        • Principal Investigator:
          • Chih-Ching Lin, MD; PhD
      • Taipei, Taiwan, 11221
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • CHIH-CHING LIN, MD

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

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • In this study, we will include 300 patients who have received 4 hours of maintenance HD therapy three times weekly for at least 3 months

Exclusion Criteria:

  • Patients with life expectancy less than 1 year
  • Patients with history of active malignancy

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
HD patients who will not receive far infrared therapy in this study.
Device: Placebo device
A device without far infrared therapy
Experimental: Far infrared therapy
In this study, 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 maintenance HD.
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/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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ANKLE BRACHIAL INDEX
Time Frame: One year
The values of the ABI were measured 10 to 30 min before HD. The ABIs will be measured by using an ABI-form device (VP1000,Colin, Komaki, Japan). The ABI will be calculated by the ratio of the ankle systolic BP divided by the arm systolic BP. The systolic BP of the arm without dialysis access and the value of the ankle systolic BP will be used for the calculation. All of the ABI and PWV will be measured twice. If the difference between them was more than 10%, a third measurement was done. The mean of the two closest values was recorded into our data base.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Markers of endothelial function
Time Frame: One year
Each time at the four different timings (from time 1 to time 4), we will collect blood sample 5 ml for measuring markers related to endothelial dysfunction, including low density lipoprotein cholesterol (LDL), high density lipoprotein cholesterol (HDL), asymmetric dimethylarginine (ADMA), hypersensitive C-reactive protein (hsCRP), matrix metalloproteinase-9 (MMP-9).
One year
PAD or cardiovascular events
Time Frame: one year
The effect of FIR on PAD or cardiovascular events during one year of follow-up will also be studied.
one year

Collaborators and Investigators

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

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Chih-Ching Lin, MD, PhD, Taipei Veterans General Hospital, Taiwan

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

March 1, 2010

Primary Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

March 28, 2010

First Submitted That Met QC Criteria

March 29, 2010

First Posted (Estimate)

March 30, 2010

Study Record Updates

Last Update Posted (Estimate)

May 27, 2010

Last Update Submitted That Met QC Criteria

May 25, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V99C1-010

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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