Photoacoustic Tomography in Assessment of Lower Extremity Artery Disease

Multistructural Quantitative Photoacoustic Imaging of Human Feet With Lower Extremity Artery Disease

Lower extremity artery disease (LEAD) is characterized by low awareness rate and high missed diagnosis rate, leading to low treatment rate and high disabling mortality rate. However, none of the current examination methods can comprehensively and thoroughly evaluate the vascular structure and blood oxygen status of the lower extremity at the same time. Photoacoustic imaging can display millimeter-scale microvessels without the need for contrast agents. The investigators developed photoacoustic tomography (PACT) technology, which wass able to provide three-dimensional and high-resolution photoacoustic images of the target area.The investigators plan to recruit LEAD patients in different disease conditions and healthy volunteers to receive the PACT examination on the feet using this imaging system, and to evaluate the potential clinical role of the imaging system in LEAD, and its added value to current imaging methods.

Study Overview

• Status: Recruiting
• Conditions: Lower Extremity; Photoacoustic
• Intervention / Treatment: Diagnostic test: Photoacoustic imaging

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jia Liu, Doctor; Phone Number: 8602085252010; Email: liujia45@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Recruiting
      • The Third Affiliated Hospital of Sun Yat-Sen University
      • Contact: 刘; Phone Number: 86+15920190962; Email: 395847853@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The LEAD patients are diagnosed as LEAD by computed tomography angiography or ultrasound.

Description

Inclusion Criteria:

1. Inclusion of the case group 1) LEAD patients; 2) Patients voluntarily take part in the study and write informed consent.
2. Inclusion of the control group 1) Patients without LEAD by ultrasound and clinical diagnosis; 2) Patients voluntarily take part in the study and write informed consent.

Exclusion Criteria:

1. age <18 years;
2. pregnant women, nursing mothers and pregnant women in preparation;
3. with laser operation contraindication (for example, received a photodynamic therapy in the last month);
4. with metal implants in lower legs or feet;
5. with a history of mental illnesses or abuse of drug and alcohol;

7) with blood phobia or pathological hypotension; 8) with cerebral hemorrhage or peripheral vascular bleeding risk, or history of stroke; 9) with wounds in lower legs or feet; 10) unable or uncooperative with the experimenter.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean vessel density of foot vasculature measured by photoacoustic imaging	Vessel density (number of vessels per mm²) in foot vasculature will be quantified using photoacoustic imaging. Results will be reported as mean ± SD.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean oxygen saturation in pedal vasculature measured by photoacoustic imaging	Oxygen saturation in pedal vasculature will be quantified by photoacoustic imaging. Results will be reported as mean ± SD. Unit of Measure: %	Baseline
Mean hemoglobin concentration in pedal vasculature measured by photoacoustic imaging	Description: Hemoglobin concentration in pedal vasculature will be quantified by photoacoustic imaging. Results will be reported as mean ± SD. Unit of Measure: g/dL	Baseline

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: II2024-189-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No