Pulse Arrival Time for Peripheral Artery Disease

Overseen By Song-Young Park

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: Aortic aneurysm, Revascularization, Walking impairments, Gangrene, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to detect peripheral artery disease (PAD), a condition that reduces blood flow to the legs. Researchers are testing whether pulse arrival time (PAT) can serve as a useful indicator of PAD. Participants will have their blood flow measured using both traditional and new methods, including the Segmental Pulse Arrival Time Assessment, and will then complete a short walking test to assess the impact on their walking. This study is suitable for adults with or without a PAD diagnosis, provided they have no other leg or foot problems. As an unphased study, it offers participants the chance to contribute to innovative research that could enhance PAD detection methods.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. It only mentions that you will need to report your medication and health history.

What prior data suggests that this investigational device is safe for assessing peripheral artery disease?

Research has shown that using segmental pulse arrival time (PAT) to check for peripheral artery disease (PAD) is generally safe. This non-invasive method avoids surgery or needles, using sensors on the skin to measure blood flow.

Studies have found that similar techniques, like plethysmography (which measures changes in body volume), are well-tolerated. Given its similarity and non-invasive nature, PAT is also expected to be safe. The available data reports no serious side effects.

Overall, PAT is considered a low-risk method for gathering information about blood flow in the legs, aiding in the detection of PAD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Segmental Pulse Arrival Time Assessment for Peripheral Artery Disease because it offers a new way to evaluate blood flow in the legs. Unlike traditional methods such as the ankle-brachial index test, which can sometimes be influenced by calcified arteries, this technique focuses on the timing of blood pulses, potentially providing a more accurate and non-invasive assessment. This could lead to earlier detection and better monitoring of the disease, ultimately improving patient outcomes.

What evidence suggests that segmental pulse arrival time is effective for detecting peripheral artery disease?

Studies have shown that measuring segmental pulse arrival time (PAT) can help detect peripheral artery disease (PAD), which affects blood flow in the legs. Research suggests that PAT might be a useful tool to identify PAD without invasive procedures. In some studies, PAT, used alongside methods like the ankle-brachial index (ABI), has shown promise in identifying blood flow problems. Evidence indicates that PAT could be especially helpful for people with diabetes, who face a higher risk of PAD. Overall, these early findings are promising, but more research is needed to fully understand its effectiveness.

In this trial, participants will visit a laboratory to be tested with the experimental PAT device, undergo an ankle-brachial index, and complete a 6-minute walking test. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Adults aged 19 or older, with or without Peripheral Artery Disease (PAD), can join this study. People are excluded if they have an aortic aneurysm, previous leg artery surgeries, walking issues not related to PAD, foot/toe gangrene or ulcers, or are pregnant/breastfeeding.

Inclusion Criteria

Be able to provide written informed consent

I am 19 years old or older.

I do not have peripheral artery disease.

Exclusion Criteria

Being currently pregnant or breastfeeding

I have gangrene or ulcers on my toes/feet.

I have had surgery to improve blood flow in my legs or aorta.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Laboratory Assessment

Participants undergo a single laboratory visit for assessment of pulse arrival time, ankle-brachial index, and a 6-minute walking test

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

No follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Segmental Pulse Arrival Time Assessment

Trial Overview The trial is testing segmental pulse arrival time (PAT) as a potential new way to detect PAD in the legs. Participants will visit the lab once for measurements including PAT and ankle-brachial index (ABI), followed by a 6-minute walk test.

How Is the Trial Designed?

Group I: Laboratory Visit #1 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07226193

Detecting Peripheral Artery Disease With the Pulse 1) The purpose of this study is to assess segmental pulse arrival time (PAT) as an alternative biomarker to detect lower-extremity ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12189656/

Forefoot Pulse Recordings for Diabetic Foot Arterial Disease Segmental pulse volume recordings at the forefoot level as a valuable diagnostic tool for detection of peripheral arterial disease in the diabetic foot ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1746809422003834

Novel & Robust Auxiliary Indicators to Ankle-Brachial Index This study investigated several novel indicators using the Detrended Fluctuation Analysis (DFA) on beat-to-beat RR interval (RRI) and pulse arrival time (PAT)

4. mdpi.com mdpi.com/2077-0383/12/18/5882

Peripheral Artery Disease & Coronary Artery Disease in CKD The absence of a pulse by palpation predicted CAD with a sensitivity of 55% and a specificity of 76%; USD showed a sensitivity of 62% and specificity of 60% to ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6462898/

How Effective Is Pulse Arrival Time for Evaluating Blood ... - PMC We decided to investigate the calculation of PAT intervals in the MIMIC database and check its usefulness for evaluating BP.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1078588406005351

Inter-Society Consensus for the Management of Peripheral ... This new consensus document has been developed with a broader international representation, including Europe, North America, Asia, Africa and Australia.

7. frontiersin.org frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2020.00720/full

Detection and Severity Assessment of Peripheral Occlusive ... This work demonstrates the initial proof-of-concept of deep learning-based arterial pulse waveform analysis for affordable and convenient PAD screening.

8. wa-provider.kaiserpermanente.org wa-provider.kaiserpermanente.org/static/pdf/hosting/clinical/criteria/pdf/plethysmography.pdf

Plethysmography | Clinical Review Criteria Segmental plethysmography (or pulse volume recording [PVR]) is a noninvasive hemodynamic measurement that can potentially provide an initial assessment of the ...