Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID06579326

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

Led by Sun Yat-sen University · Updated on 2026-05-06

200

Participants Needed

1

Research Sites

13 weeks

Total Duration

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AI-Summary

What this Trial Is About

Lower extremity artery disease (LEAD) is often underdiagnosed and untreated, leading to serious disability and death. Researchers are studying a new imaging method called photoacoustic tomography (PACT) to better evaluate the blood vessels and oxygen levels in the feet of people with LEAD. This technology can create detailed three-dimensional images without using contrast agents, potentially offering more complete information than current tests. Participants in this observational study will include both LEAD patients and healthy volunteers. They will undergo PACT imaging of their feet, which uses special ultrasound and photoacoustic techniques to capture high-resolution images of blood vessels and measure blood oxygen saturation and hemoglobin concentration. The study aims to assess how well this imaging method works and whether it adds value compared to existing diagnostic tools. During the study, participants will have their foot vasculature examined using the PACT system. Researchers will measure vessel density, oxygen saturation, and hemoglobin levels at baseline. The study involves no treatment and focuses on gathering detailed imaging data. Participants will be monitored for safety, and the study will run until the end of 2028, with involvement lasting as needed for imaging and assessments.

CONDITIONS

Brief Title

Photoacoustic Tomography in Assessment of Lower Extremity Artery Disease

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • LEAD patients who voluntarily agree to participate and provide informed consent
  • Patients without LEAD confirmed by ultrasound and clinical diagnosis who voluntarily agree to participate and provide informed consent
  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Pregnant women, nursing mothers, or women preparing for pregnancy
  • Individuals with contraindications to laser operation, such as recent photodynamic therapy within the last month
  • Presence of metal implants in lower legs or feet
  • History of mental illness or abuse of drugs and alcohol
  • Blood phobia or pathological hypotension
  • History of cerebral hemorrhage, peripheral vascular bleeding risk, or stroke
  • Presence of wounds on lower legs or feet
  • Inability or unwillingness to cooperate with the study procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline

Participants undergo photoacoustic imaging to assess vessel density, oxygen saturation, and hemoglobin concentration in the foot vasculature.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

the Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China, 510630

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Research Team

J

Jia Liu, Doctor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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