Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention

NCT06544135 | Recruiting FDA Device

• 1 other identifier: STUDY20230726
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 3

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?

Conditions

Peripheral Arterial Disease; Critical Limb Ischemia; Critical Lower Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• Change in ABI

  Ankle brachial index will be taken before and after intervention and correlated with thermal readings from FLIR.

  Up to 90 days before revascularization; Up to 1 year after revascularization

Secondary Outcomes (3)

• Major amputations

  Up to 1 year after revascularization

• Major revascularizations post-initial intervention

  Up to 1 year after revascularization

• Mortality

  Up to 1 year after revascularization

Study Arms (1)

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

Interventions

FLIR One Pro LT DEVICE

Thermal imaging camera used to measure temperatures of the lower limb.

FLIR thermal imaging group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People between ages 18 and 99 years with lower extremity peripheral artery disease with a planned endovascular intervention.

You may qualify if:

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

You may not qualify if:

• Non-arterial ulcers
• Pregnant

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (3)

University Hospitals Ahuja Medical Center

Beachwood, Ohio, 44122, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

University Hospitals Parma Medical Center

Parma, Ohio, 44129, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Jun Li, MD

  University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Li, MD

CONTACT

(734) 968-5212; jun.li@uhhospitals.org

Grace Craig, DPM

CONTACT

408 628 8102; gracecraigdpm@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: August 9, 2024
• Study Start: April 14, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)