Evaluating Peripheral Arterial Disease with Near-infrared Spectroscopy
Study to Use Change in Near Infrared Spectroscopy Assessment of Tissue Oxygenation During a Provocative Leg Maneuver to Assess Peripheral Artery Disease State.
This study is testing if a special imaging technique called Near-infrared spectroscopy can better help doctors understand how severe Peripheral Arterial Disease is during a specific test.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 35 Years to 99 Years |
| Sex | All |
| Sponsor | Kent Imaging Inc Industry-sponsored |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT06237621 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of Near-infrared spectroscopy (NIRS) in evaluating the severity of Peripheral Arterial Disease (PAD) during a specific test called the Provocative Elevation Maneuver of the Lower Extremity (PEMLE). Participants will undergo a single visit where they will be screened and enrolled during a regular clinic appointment. The study will compare the results from NIRS imaging to routine clinical assessments to determine its accuracy in diagnosing PAD.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 35-99 who have at least one intact forefoot and can perform the required leg positions.
Not a fit: Patients who have had a transmetatarsal amputation or higher on both limbs, or those who have undergone vascular intervention within the past year, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate and non-invasive method for assessing Peripheral Arterial Disease.
How similar studies have performed: While the use of NIRS in PAD assessment is a novel approach, similar studies have shown promise in utilizing advanced imaging techniques for vascular evaluations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Antonio, Texas
- University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Sunny Sajjad, DPM
- Email: sajjad@uthscsa.edu
- Phone: (210) 567-5131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.