An observational study in Lower Extremity and Photoacoustic, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Sun Yat-sen University · Observational
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.
Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The LEAD patients are diagnosed as LEAD by computed tomography angiography or ultrasound.
Exclusion Criteria:
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.
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.
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.
Time frame: Baseline
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: %
Time frame: 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
Time frame: Baseline
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