Detecting Peripheral Artery Disease With the Pulse

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT07226193
Status
Recruiting
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Conditions

  • Peripheral Artery Disease (PAD)

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Segmental pulse arrival time assessment — DEVICE
    A proprietary device has been developed to obtain segmental pulse arrival times in the arms and legs. Using this information, the propagation time of the pulse is being investigated as a biomarker to detect the presence of lower-extremity atherosclerosis. Furthermore, the impacts of aging on the biomarker will be assessed.

Study Details

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 a finger on each hand 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 arm and legs will be assessed at the end of each stage. Thermal images of the fingers and toes will be assessed before using the investigational device and after each stage. 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.

Key Dates

Start date
Feb 5, 2026
Status verified
Feb 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

Segmental pulse arrival times [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska at Omaha Health Science CollaborativeOmahaNebraska68182
Cody P Anderson
[email protected]
402-237-6539

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By research site
University of Nebraska at Omaha Health Science Collaborative· Omaha, NE

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