Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FLIR One Pro LT.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease, Critical Limb Ischemia, Critical Lower Limb Ischemia. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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?
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.
Interventions
- Device FLIR One Pro LT
Thermal imaging camera used to measure temperatures of the lower limb.
Primary outcome measures
- Change in ABI [Time frame: Up to 90 days before revascularization; Up to 1 year after revascularization]
Secondary outcome measures (3)
- Major amputations [Time frame: Up to 1 year after revascularization]
- Major revascularizations post-initial intervention [Time frame: Up to 1 year after revascularization]
- Mortality [Time frame: Up to 1 year after revascularization]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- University Hospitals Ahuja Medical Center — Beachwood
- University Hospitals Cleveland Medical Center — Cleveland
- University Hospitals Parma Medical Center — Parma
Identifiers
NCT: NCT06544135 · STUDY20230726