NCT06579326 Photoacoustic Tomography in Assessment of Lower Extremity Artery Disease
| NCT ID | NCT06579326 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-sen University |
| Condition | Lower Extremity |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-11-01 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06579326 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lower Extremity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06579326 currently recruiting?
Yes, NCT06579326 is actively recruiting participants. Contact the research team at liujia45@mail.sysu.edu.cn for enrollment information.
Where is the NCT06579326 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06579326 clinical trial?
NCT06579326 is sponsored by Sun Yat-sen University. The trial plans to enroll 200 participants.