Photoacoustic Tomography in Assessment of Lower Extremity Artery Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Photoacoustic imaging.
- Who it may be relevant to
- Registry conditions: Lower Extremity, Photoacoustic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multistructural Quantitative Photoacoustic Imaging of Human Feet With Lower Extremity Artery Disease
Overview
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.
Interventions
- Diagnostic test Photoacoustic imaging
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.
Primary outcome measures
- Mean vessel density of foot vasculature measured by photoacoustic imaging [Time frame: Baseline]
Secondary outcome measures (2)
- Mean oxygen saturation in pedal vasculature measured by photoacoustic imaging [Time frame: Baseline]
- Mean hemoglobin concentration in pedal vasculature measured by photoacoustic imaging [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- Inclusion of the case group 1) LEAD patients; 2) Patients voluntarily take part in the study and write informed consent.
- 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
- age <18 years;
- pregnant women, nursing mothers and pregnant women in preparation;
- with laser operation contraindication (for example, received a photodynamic therapy in the last month);
- with metal implants in lower legs or feet;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- the Third Affiliated Hospital of Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT06579326 · II2024-189-02