Critical Limb Ischemia, Critical Lower Limb Ischemia, Peripheral Arterial Disease
Conditions
Brief summary
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
DEVICEFLIR One Pro LT
Thermal imaging camera used to measure temperatures of the lower limb.
Sponsors
University Hospitals Cleveland Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ABI | Up to 90 days before revascularization; Up to 1 year after revascularization | Ankle brachial index will be taken before and after intervention and correlated with thermal readings from FLIR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major amputations | Up to 1 year after revascularization | Any associated amputations the subject had after revascularization |
| Major revascularizations post-initial intervention | Up to 1 year after revascularization | Any revascularization procedures done after the initial revascularization |
| Mortality | Up to 1 year after revascularization | Subject deaths during the length of the study |
Countries
United States
Contacts
CONTACTJun Li, MD
CONTACTGrace Craig, DPM
PRINCIPAL_INVESTIGATORJun Li, MD
University Hospitals
Outcome results
None listed