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 range35 Years – 99 Years

SexALL

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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

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