Purpose

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?

Conditions

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Lower extremity peripheral artery disease with tissue loss consistent with Rutherford classification V or VI. - Planned lower extremity endovascular intervention

Exclusion Criteria

  • Non-arterial ulcers - Pregnant

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
FLIR thermal imaging group Temperature measurements will be taken of the lower limb using the FLIR camera and correlated with other aspects of each patient.
  • Device: FLIR One Pro LT
    Thermal imaging camera used to measure temperatures of the lower limb.

Recruiting Locations

University Hospitals Ahuja Medical Center
Beachwood, Ohio 44122
Contact:
Jun Li, MD

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
Contact:
Jun Li, MD
440-882-0075
Jun.Li@UHhospitals.org

University Hospitals Parma Medical Center
Parma, Ohio 44129
Contact:
Jun Li, MD

More Details

Status
Recruiting
Sponsor
University Hospitals Cleveland Medical Center

Study Contact

Jun Li, MD
(734) 968-5212
jun.li@uhhospitals.org

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.