Recruiting

Segmental PAT

Sponsor:

University of Nebraska

Code:

NCT07226193

Conditions

Peripheral Artery Disease (PAD)

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

Interventions

Segmental pulse arrival time assessment

Study Details

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 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.

Conditions

Peripheral Artery Disease (PAD)

Study ID

NCT07226193

Start date

Feb 5, 2026

Status verified date

Feb, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

Segmental pulse arrival time assessment

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.

Primary outcome measure

  • Segmental pulse arrival times [ Time Frame: Day 1 ]
  • Ankle-brachial index [ Time Frame: Day 1 ]
  • 6-min walking distance [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Locations

University of Nebraska at Omaha Health Science Collaborative

Recruiting

Omaha, Nebraska, United States, 68182

Contacts

More Information

Sponsor

University of Nebraska

Last update posted

May 19, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-05-19.