Photoacoustic imaging of blood vessels and oxygen in the lower leg and foot
Multistructural Quantitative Photoacoustic Imaging of Human Feet With Lower Extremity Artery Disease
This observational project will try a non-contrast photoacoustic scan of the feet to see if it can show blood vessel structure and oxygen levels in people with and without lower extremity artery disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06579326 on ClinicalTrials.gov |
What this trial studies
Researchers will enroll adults with diagnosed lower extremity artery disease (LEAD) and healthy volunteers to undergo three-dimensional photoacoustic computed tomography (PACT) scans of the feet. The PACT system produces high-resolution images of millimeter-scale microvessels and can estimate blood oxygenation without using contrast agents. Imaging findings will be compared with standard clinical evaluations and ultrasound to determine what additional vascular and oxygenation information PACT provides. The study is observational and aims to define PACT's feasibility and potential clinical role across different stages of LEAD.
Who should consider this trial
Good fit: Ideal candidates are adults with diagnosed lower extremity artery disease as well as adults without LEAD who can give informed consent and have no contraindications to laser imaging.
Not a fit: People under 18, pregnant or nursing individuals, anyone with metal implants in the lower legs or feet, active wounds, recent photodynamic therapy, bleeding risk, severe cooperation issues, or a history of certain mental health or substance abuse conditions may not benefit or be eligible.
Why it matters
Potential benefit: If successful, the technique could provide a noninvasive way to visualize small blood vessels and oxygen levels in the lower limb, improving detection and treatment planning.
How similar studies have performed: Photoacoustic imaging has shown promising preclinical and early clinical results for microvascular and oxygenation imaging, but its use specifically for routine LEAD diagnosis remains relatively novel and still under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- the Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Jia Liu, Doctor
- Email: liujia45@mail.sysu.edu.cn
- Phone: 8602085252010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.