Lower ExtremityNCT06579326
Photoacoustic Tomography in Assessment of Lower Extremity Artery Disease
An observational study of Lower Extremity and Photoacoustic, run by Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Extremity, Photoacoustic
- What is being tested?
- Photoacoustic imaging
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The LEAD patients are diagnosed as LEAD by computed tomography angiography or ultrasound.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
刘, 86+15920190962, 395847853@qq.com
About this study
Official title: Multistructural Quantitative Photoacoustic Imaging of Human Feet With Lower Extremity Artery Disease
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.
- Conditions
- Lower Extremity, Photoacoustic
- Being tested
- Photoacoustic imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photoacoustic imagingDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean vessel density of foot vasculature measured by photoacoustic imaging
Vessel density (number of vessels per mm²) in foot vasculature will be quantified using photoacoustic imaging. Results will be reported as mean ± SD.
Measured: Baseline
Secondary outcomes (2)
Mean oxygen saturation in pedal vasculature measured by photoacoustic imaging
Oxygen saturation in pedal vasculature will be quantified by photoacoustic imaging. Results will be reported as mean ± SD. Unit of Measure: %
Measured: Baseline
Mean hemoglobin concentration in pedal vasculature measured by photoacoustic imaging
Description: Hemoglobin concentration in pedal vasculature will be quantified by photoacoustic imaging. Results will be reported as mean ± SD.
Unit of Measure: g/dL
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Nov 2024
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower ExtremityStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia Liu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579326
- Sponsor's protocol ID
- II2024-189-02
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2024
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multistructural Quantitative Photoacoustic Imaging of Human Feet With Lower Extremity Artery Disease
- ClinicalTrials.gov ID
- NCT06579326
- Acronym / sponsor ID
- II2024-189-02
- Conditions
- Lower Extremity, Photoacoustic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The LEAD patients are diagnosed as LEAD by computed tomography angiography or ultrasound.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photoacoustic imagingIt 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. | Diagnostic test | – |
Primary outcome
Mean vessel density of foot vasculature measured by photoacoustic imaging
Time frame: Baseline
Vessel density (number of vessels per mm²) in foot vasculature will be quantified using photoacoustic imaging. Results will be reported as mean ± SD.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Extremity and Photoacoustic, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia Liu, Doctor (8602085252010, liujia45@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean vessel density of foot vasculature measured by photoacoustic imaging (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.