Clinical trial NCT06237621: Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment
Official title: Study to Use Change in Near Infrared Spectroscopy Assessment of Tissue Oxygenation During a Provocative Leg Maneuver to Assess Peripheral Artery Disease State.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Disease
Keywords: Ankle-brachial index
Tissue Oxygen Saturation
Near infrared spectroscopy
NIR
Peripheral Arterial Disease
PAD
CLI
Provocative Leg Maneuver
PAD screening
Lead sponsor: Kent Imaging Inc
Sponsor class: INDUSTRY
Collaborators: name: The University of Texas Health Science Center at San Antonio
First posted: 2024-02-01
Enrollment: 150
Sex: ALL
Minimum age (years): 35
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be enrolled through the PI's clinic population. Healthy volunteers will be recruited from the clinic staff population and other volunteers recruited from healthy clinic visitors. Subjects who are identified for study participation will be screened for all eligibility requirements. Those meeting eligibility criteria for the study will have the study explained to them by the study staff. An Informed Consent Form will be provided to sign, prior to undergoing any study procedures. Subjects will be encouraged to ask questions of the study staff. There is no cap on the number of subjects that can be screened. Additional subjects will continue to be recruited as needed to reach the total study enrollment of 250 limbs.

Brief 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.

Detailed description: This study is designed as a prospective observational study to assess the effectiveness of NIRS to accurately evaluate the degree of PAD, as compared to routine clinical assessment, during the PEMLE test protocol. This will be a single visit study where subjects will be screened and enrolled during a regular clinic visit.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Comparing change in plantar foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test paired with the presence/absence of diabetes to the SOC clinical assessment of PAD
timeFrame: 1-2 days
measure: Comparing change in dorsal 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
measure: Change of NIRS measurements with other positions
timeFrame: 1-2 days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
References: