RecruitingNot Applicable

Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment

United States150 participantsStarted 2024-02-12

Plain-language summary

The objective of this trial is to determine if Near-infrared spectroscopy (NIRS) can accurately evaluate the degree of Peripheral Arterial Disease (PAD) during a Provocative Elevation Maneuver of the Lower Extremity (PEMLE) test, as compared to routine clinical assessments.

Who can participate

Age range

35 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 35-99 years of age * Subject has at least 1 intact forefoot * Can achieve leg positions to complete the study Exclusion Criteria: * The subject is unwilling or unable to comply with the protocol or scheduled appointments. * The subject has had transmetatarsal amputation or higher on both limbs. * Vascular intervention within the past year * Subjects who have had a previous distal bypass procedure * Pregnant or plans to become pregnant * Deemed by the PI to be unsuitable for the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comparing change in plantar foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test to the SOC clinical assessment of PAD

Timeframe: 1-2 days

Trial details

NCT IDNCT06237621

SponsorKent Imaging Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12

Contact for this trial

Sunny Sajjad, DPM

(210) 567-5131 sajjad@uthscsa.edu

View on ClinicalTrials.gov More Peripheral Arterial Disease trials

Who can participate

Age range

35 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.