Pulse Arrival Time as an Alternative Biomarker to Detect Lower-Extremity Peripheral Artery Disease

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

1\) The purpose of this study is to assess segmental pulse arrival time (PAT) as an alternative biomarker to detect lower-extremity peripheral artery disease (PAD), and to investigate the impacts of local skin heating and foot elevation. The secondary purpose will be to investigate the impacts of age on segmental PAT. The subject population will include any adults 19 years of age or older with or without PAD. Exclusion criteria include having an aortic aneurysm with or without previous intervention, previous revascularization surgeries of the arteries in the legs/aorta, walking impairments independent of PAD, gangrene or ulcers of the toes/feet, and currently pregnant or breastfeeding. 3) All aims of the present study will be completed with a single laboratory visit. Descriptive measurements will include height, weight, age, sex, body fat percentage, and self-reported medication and health history. Subjects will lie in the supine position for 20-min. After rest, either the ankle-brachial index (ABI) or PAT will be assessed. After 10-min of further rest, the other measurement will be performed. ABIs will be assessed according to current guidelines: blood pressures will be assessed in the dorsal pedis and tibialis posterior arteries of both legs and the brachial arteries of both arms using a blood pressure cuff and Doppler ultrasound. PAT will be simultaneously assessed in both arms and legs using an investigational device with a 3-lead electrocardiogram sensor and four photoplethysmography (PPG) sensors. A PPG sensor will be applied to both middle fingers and both big toes. Signals will be collected for 15-min with finger and toe sensor temperatures at 30 C. Toe sensor temperature will then be elevated to 45 C for 15-min. Finally, toe sensor temperature will remain at 45 C, and the feet will be elevated 8-in with a soft cushion for 15-min. Blood pressure in the foot will be assessed before and after foot elevation with Doppler ultrasound. Thermal images of the fingers and toes will be assessed before and after using the investigational device. Subjects will then participate in a 6-min walking test (6MWT) to objectively establish walking capacity. The 6MWT will be performed in accordance with current guidelines. Segmental PATs will be compared with ABI and 6-min walking time to determine if segmental PATs can predict lower-extremity PAD (ABI) and the associated walking impairment (6MWT). This study is expected to last \ 2.5hrs. 4) There will be no follow-up.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: t
View:

• be able to provide written informed consent

• be 19 years of age or older

• having or not having a diagnosis of peripheral artery disease

Locations
United States
Nebraska
University of Nebraska at Omaha Health Science Collaborative
RECRUITING
Omaha
Contact Information
Primary
Cody P Anderson
codypanderson@unomaha.edu
402-237-6539
Backup
Song-Young Park
song-youngpark@unomaha.edu
402-554-3374
Time Frame
Start Date: 2026-02-05
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 40
Treatments
Experimental: Laboratory Visit #1
During the first and only laboratory visit, subjects will be tested 1) with the experimental device, 2) an ankle-brachial index will be performed, and 3) a 6-min walking test will be performed.
Sponsors
Leads: University of Nebraska

This content was sourced from clinicaltrials.gov

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