Detecting lower‑leg peripheral artery disease using segmental pulse arrival time
Pulse Arrival Time as an Alternative Biomarker to Detect Lower-Extremity Peripheral Artery Disease
NA · University of Nebraska · NCT07226193
This trial will test whether measuring segmental pulse arrival time, and whether warming the skin or elevating the foot, can help detect lower‑leg peripheral artery disease in adults aged 19 and older.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of Nebraska (other) |
| Locations | 1 site (Omaha, Nebraska) |
| Trial ID | NCT07226193 on ClinicalTrials.gov |
What this trial studies
Adults 19 years and older with or without peripheral artery disease will complete a single laboratory visit with brief health and medication history, height/weight and body composition measured by bioelectrical impedance, and baseline rest in the supine position. Investigators will record segmental pulse arrival times and compare them to ankle‑brachial index and 6‑minute walk test results to see if PAT predicts PAD. The protocol includes experiments to test whether local toe/foot heating and foot elevation change PAT measurements and whether those changes improve PAD detection. The study will also analyze how age affects segmental PAT values.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 or older who can give informed consent and lie supine for testing, whether they have known PAD or not, and who do not have the listed exclusion conditions.
Not a fit: People with a current or prior aortic aneurysm, prior leg or aortic revascularization, walking impairments unrelated to limb ischemia, toe or foot gangrene or ulcers, or who are pregnant or breastfeeding may not be eligible or receive benefit from this test.
Why it matters
Potential benefit: If successful, this approach could provide a simple, portable way to detect or screen for lower‑extremity PAD without complex imaging, enabling earlier diagnosis and monitoring.
How similar studies have performed: Pulse arrival time has been studied for arterial stiffness and central hemodynamics, but using segmental PAT specifically to detect lower‑extremity PAD is relatively novel with limited prior validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Omaha, Nebraska
- University of Nebraska at Omaha Health Science Collaborative — Omaha, Nebraska, United States (RECRUITING)
Study contacts
- Study coordinator: Cody P Anderson
- Email: codypanderson@unomaha.edu
- Phone: 402-237-6539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Artery Disease, pulse arrival time, atherosclerosis, peripheral artery disease, portable peripheral artery disease detection