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NCT Number: NCT06579326

Photoacoustic Tomography in Assessment of 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.

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Key information

Conditions

Lower Extremity Photoacoustic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

the Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location status: Recruiting

Location contact

刘

CONTACT

[email protected]

86+15920190962

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion of the case group 1) LEAD patients; 2) Patients voluntarily take part in the study and write informed consent.
  • 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

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

Treatment and study plan

Photoacoustic imaging

Diagnostic Test

It could provide three-dimensional ultrasound images of vessels in the target area. It could also provides super-resolution and large-depth photoacoustic images. By effectively extracting photoacoustic spectral features and using spectral feature unmixing algorithm, blood oxygen saturation can be calculated.

Primary outcomes

  1. Mean vessel density of foot vasculature measured by photoacoustic imaging

    Time frame: Baseline

    Vessel density (number of vessels per mm²) in foot vasculature will be quantified using photoacoustic imaging. Results will be reported as mean ± SD.

Secondary outcomes

  1. Mean oxygen saturation in pedal vasculature measured by photoacoustic imaging

    Time frame: Baseline

    Oxygen saturation in pedal vasculature will be quantified by photoacoustic imaging. Results will be reported as mean ± SD. Unit of Measure: %

  2. Mean hemoglobin concentration in pedal vasculature measured by photoacoustic imaging

    Time frame: Baseline

    Description: Hemoglobin concentration in pedal vasculature will be quantified by photoacoustic imaging. Results will be reported as mean ± SD.

    Unit of Measure: g/dL

Study contacts

Contact information is provided by the study sponsor or research team.

Jia Liu, Doctor

CONTACT

[email protected]

8602085252010

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 30, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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