Far Infrared Therapy on Peripheral Artery Disease in Hemodialysis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT01095549
First received: March 28, 2010
Last updated: May 25, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Peripheral Artery Disease
Device: WSTM TY101 FIR emitter (Far infrared therapy)
Device: Placebo device
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Peripheral Artery Disease in Patients on Maintenance Hemodialysis: Risk Factors and the Effect of FIR Therapy

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • ANKLE BRACHIAL INDEX [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Markers of endothelial function [ Time Frame: One year ] [ Designated as safety issue: No ]
    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).

  • PAD or cardiovascular events [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    The effect of FIR on PAD or cardiovascular events during one year of follow-up will also be studied.


Estimated Enrollment: 300
Study Start Date: March 2010
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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〈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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01095549

Contacts
Contact: Hsiao-Di Cheng, BSc 886-2-28712121 ext 2061 p20039@hotmail.com

Locations
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Principal Investigator: Chih-Ching Lin, MD; PhD         
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11221
Contact: CHIH-CHING LIN, MD    886-2-28712121 ext 2970    lincc2@vghtpe.gov.tw   
Principal Investigator: CHIH-CHING LIN, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: Chih-Ching Lin, MD, PhD Taipei Veterans General Hospital, Taiwan
  More Information

No publications provided

Responsible Party: CHIH-CHING LIN, Taipei Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01095549     History of Changes
Other Study ID Numbers: V99C1-010
Study First Received: March 28, 2010
Last Updated: May 25, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Taipei Veterans General Hospital, Taiwan:
ankle-brachial index (ABI)
brachial-ankle pulse wave velocity (baPWV)
far infrared therapy (FIR)
hemodialysis (HD)
peripheral artery disease (PAD)
Peripheral artery disease in hemodialysis

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on September 14, 2014