Far Infrared Therapy on Peripheral Artery Disease in Hemodialysis Patients
Peripheral Artery Disease in Patients on Maintenance Hemodialysis: Risk Factors and the Effect of FIR Therapy
1 other identifier
interventional
300
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
2 active sites
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
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 28, 2010
CompletedFirst Posted
Study publicly available on registry
March 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedMay 27, 2010
March 1, 2010
1.1 years
March 28, 2010
May 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ANKLE BRACHIAL INDEX
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 Outcomes (2)
Markers of endothelial function
One year
PAD or cardiovascular events
one year
Study Arms (2)
Control group
PLACEBO COMPARATORHD patients who will not receive far infrared therapy in this study.
Far infrared therapy
EXPERIMENTALIn 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with life expectancy less than 1 year
- Patients with history of active malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Taipei Veterans General Hospital
Taipei, Taiwan, 11221, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 112, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chih-Ching Lin, MD, PhD
Taipei Veterans General Hospital, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
March 28, 2010
First Posted
March 30, 2010
Study Start
March 1, 2010
Primary Completion
April 1, 2011
Last Updated
May 27, 2010
Record last verified: 2010-03