Clinical trial NCT06579326: Photoacoustic Tomography in Assessment of Lower Extremity Artery Disease
Official title: Multistructural Quantitative Photoacoustic Imaging of Human Feet With Lower Extremity Artery Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lower Extremity
Photoacoustic
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The LEAD patients are diagnosed as LEAD by computed tomography angiography.

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. This study aims to evaluate the reliability and accuracy of photoacoustic tomography (PACT) in the diagnosis of lower limb arterial disease through a case-control study. It is planned to recruit 30 patients with clinically confirmed LEAD (15 patients with stenosis ≥50% and \< 50% respectively) and 5 patients without LEAD in preliminary clinical screening. The reliability of PACT was assessed by repeated measurements within the observer and different inter-observer measurements of the same subject. Compared with computed tomographic angiography (CTA), the sensitivity and specificity of PACT in diagnosing vascular stenosis were calculated. The ability of PACT to determine tissue blood oxygen was assessed by comparing PACT functional imaging with ischemic grading as determined by ankle-brachial index (ABI) and transcutaneous oxygen pressure (TcpO2) between subgroups.


Eligibility criteria: Inclusion Criteria:

1. LEAD patients with involvement of calf arteries;
2. the glomerular filtration rate (GFR) \&gt; 60 ml/min.
3. 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) the glomerular filtration rate (GFR) \&gt; 60 ml/min. 3) Patients voluntarily take part in the study and write informed consent.

Exclusion Criteria:

1. age \&lt; 18 years;
2. pregnant women, nursing mothers and pregnant women in preparation;
3. allergic to CTA contrast agents;
4. with laser operation contraindication (for example, received a photodynamic therapy in the last month);
5. with metal implants in lower legs or feet;
6. 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.

Primary outcomes:
measure: Stenosis degree of calf artery
timeFrame: Baseline
Secondary outcomes:
measure: Calf tissue blood oxygen
timeFrame: Baseline
Other outcomes:
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Study officials:
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