Recruiting

Observational Study

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT06544135

Conditions

Peripheral Arterial Disease

Critical Limb Ischemia

Critical Lower Limb Ischemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

FLIR One Pro LT

Study Details

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

Study ID

NCT06544135

Start date

Apr 14, 2025

Status verified date

Jul, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

FLIR One Pro LT

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

Primary outcome measure

  • Change in ABI [ Time Frame: Up to 90 days before revascularization; Up to 1 year after revascularization ]

Central Contacts and Locations

Locations

University Hospitals Ahuja Medical Center

Recruiting

Beachwood, Ohio, United States, 44122

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

University Hospitals Parma Medical Center

Recruiting

Parma, Ohio, United States, 44129

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Jul 2, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-07-02.