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NCT Number: NCT06237621

Using SnapshotNIR With Provocative Leg Maneuver for PAD Assessment

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

35 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location status: Recruiting

Location contact

Henrik Claeson

CONTACT

[email protected]

210-567-8279

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SnapshotNIR imaging

Device

SnapshotNIR will be used for tissue oxygen-saturation imaging of all the subjects' foot along with standard of care procedures for PAD assessment.

Primary outcomes

  1. 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

    Time frame: 1-2 days

    The significance of the relationship will be evaluated using an analysis of variance (ANOVA) where the independent variable will be the SOC assessment of PAD and the dependent variable will be the difference in NIRS measurement between the initial position (supine) and the second position (elevated leg).

Secondary outcomes

  1. 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

    Time frame: 1-2 days

    This outcome will be evaluated using an analysis of variance (ANOVA) with two independent variables (factors) including the SOC assessment of PAD and the presence of diabetes (present or not) and the dependent variable will be the difference in NIRS measurement between the initial position (supine) and the second position (elevated leg).

  2. 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

    Time frame: 1-2 days

    This outcome will be evaluated in a similar fashion as the analysis from the primary outcome but with the dependent variable will be calculated based on measurements taken from the dorsal surface of the foot which will be evaluated against the independent variable (SOC assessment) via ANOVA.

  3. Change of NIRS measurements with other positions

    Time frame: 1-2 days

    This outcome will be evaluated in a similar fashion as the analysis from the primary outcome but with the dependent variable being the difference in NIRS measurement between the raised and dependent position (patient sitting up) and then the baseline and dependent position which will be evaluated against the independent variable (SOC assessment) via ANOVA.

Study contacts

Contact information is provided by the study sponsor or research team.

Sunny Sajjad, DPM

CONTACT

[email protected]

(210) 567-5131

Sponsors and collaborators

Lead sponsor

Kent Imaging Inc

Industry

Collaborators

  • The University of Texas Health Science Center at San Antonio

Registry information

Official study title

Study to Use Change in Near Infrared Spectroscopy Assessment of Tissue Oxygenation During a Provocative Leg Maneuver to Assess Peripheral Artery Disease State.

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 1, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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