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This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure. The main question this study aims to answer is: \- Are temperature measurements from a forward looking infrared (FLIR) camera of the lower extremity useful in predicting outcome of revascularization procedures?
This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure. Patients with lower extremity PAD will be seen in office pre-intervention. Consent to participate in the TIC study will be acquired at this point. Patients will be given a physical copy of their consent form at the time consent is obtained. During this initial visit or subsequent pre-procedural office visit, the smartphone-based thermal camera will be utilized to measure the temperature of the lower extremity foot, ankle, and leg at the plantar, dorsal, and lateral distributions. Comorbidities and demographic factors will be documented from medical records at this time as well. Data will be gathered at a consistent location to minimize impact of room temperature on measurements. Patients will then undergo scheduled revascularization with the interventionist. Post-intervention pictures will be taken immediately after revascularization. Patients will then be seen again by the research team for follow-up thermal camera imaging, 1 week post-intervention, and weekly post intervention for at least 1 month but up to 6 months. Thermal measurements will be correlated with intra-op imaging and clinical outcomes in data analysis.
Age
18 - 99 years
Sex
ALL
Healthy Volunteers
No
University Hospitals Ahuja Medical Center
Beachwood, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
University Hospitals Parma Medical Center
Parma, Ohio, United States
Start Date
April 14, 2025
Primary Completion Date
October 1, 2027
Completion Date
October 1, 2027
Last Updated
May 13, 2025
25
ESTIMATED participants
FLIR One Pro LT
DEVICE
Lead Sponsor
University Hospitals Cleveland Medical Center
NCT07472049
NCT07161583
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07322913