Detecting Peripheral Artery Disease With the Pulse

NCT07226193 | Recruiting FDA Device

• 1 other identifier: 0685-25-EP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Artery Disease (PAD)

Keywords

pulse arrival time; atherosclerosis; peripheral artery disease; portable peripheral artery disease detection

Outcome Measures

Primary Outcomes (3)

• Segmental pulse arrival times

  Pulse arrival time will be assessed in both arms and legs with the investigational device

  Day 1

• Ankle-brachial index

  Segmental blood pressures in the arms and ankles will be assessed as an index of the presence and/or severity of lower-extremity atherosclerosis. The ankle-brachial index is the standard screening assessment for peripheral artery disease in the lower-extremities.

  Day 1

• 6-min walking distance

  The 6-min walking test is a standard assessment of mobility in older adults and in patients with peripheral artery disease. The 6-min walking test will be performed to quantify the level of walking impairment in patients with peripheral artery disease.

  Day 1

Study Arms (1)

Laboratory Visit #1

EXPERIMENTAL

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.

Device: Segmental pulse arrival time assessment

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.

Laboratory Visit #1

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be able to provide written informed consent
• be 19 years of age or older
• having or not having a diagnosis of peripheral artery disease

You may not qualify if:

• having a current or pervious aortic aneurysm with or without previous intervention
• having previous revascularization surgeries (open or endovascular) of the legs or aorta
• having walking impairments independent of lower-limb ischemia (e.g., musculoskeletal injury)
• having gangrene or ulcers of the toes/feet
• being currently pregnant or breastfeeding

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska at Omaha Health Science Collaborative

Omaha, Nebraska, 68182, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Cody P Anderson

CONTACT

402-237-6539; codypanderson@unomaha.edu

Gwenael Layec, PhD

CONTACT

4025542719; glayec@unomaha.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To address the objective of Specific Aim #1 \& #2, two groups of participants are defined as needing to complete the study: 1) patients with peripheral artery disease and 2) age-matched controls. All participants will participate in a single laboratory visit where 1) the experimental device will be tested, 2) an ankle-brachial index will be performed, and 3) a 6-min walking test will be performed. To address the objectives of Specific Aim #3, two groups of participants are defined as needing to complete the study: 1) younger adults (19-54 yrs) and 2) older adults (+55 yrs). All participants will participate in a single laboratory visit where 1) the experimental device will be tested, 2) an ankle-brachial index will be performed, and 3) a 6-min walking test will be performed.

Study Record Dates

• First Submitted: October 30, 2025
• First Posted: November 10, 2025
• Study Start: February 5, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)