Foot UlcerNCT07216599
Photoacoustic Imaging of Foot Wound
A study testing Photoacoustic imaging and multispectral imaging in people with Foot Ulcer, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
This pilot device trial aims to test the feasibility of using photoacoustic images to monitor tissue perfusion and to guide post-surgical wound treatment. Through this pilot study, the investigators will test the feasibility, identify any practical issues, and acquire essential information (e.g., drop-off rate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulcer
- What is being tested?
- Photoacoustic imaging and multispectral imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a chronic wound on the foot that is presumed to be due to arterial insufficiency.
Who cannot join
- Patients with a massive deep tissue infection.
- Patients with preexisting skin conditions, such as melanoma, psoriasis, in areas close to the wound(s).
- Noncompliant patients who do not adhere to care plans.
- Pregnant women.
- Adults unable to consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UBMD Vascular Surgery
Buffalo, New York, 14221
About this study
Official title: Photoacoustic Imaging in Wound Evaluation and Treatment Guidance
This pilot device trial aims to test the feasibility of using photoacoustic images to monitor tissue perfusion and to guide post-surgical wound treatment. Through this pilot study, the investigators will test the feasibility, identify any practical issues, and acquire essential information (e.g., drop-off rate, variation in wound healing rate) to guide future large-scale studies.
Read the detailed description
This pilot device trial aims to test the feasibility of using photoacoustic images to monitor tissue perfusion and to guide post-surgical wound treatment. Through this pilot study, the investigators will test the feasibility, identify any practical issues, and acquire essential information (e.g., drop-off rate, variation in wound healing rate) to guide future large scale studies.
For recruited patients, wound care will be guided by both photoacoustic imaging and Kent imaging, a multi-spectral imaging technique for tissue oxygenation mapping. None of the techniques is currently used in the clinic as standard care.
- Conditions
- Foot Ulcer
- Being tested
- Photoacoustic imaging and multispectral imaging
- Medical subject headings
- Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photoacoustic imaging and multispectral imagingDevice
Use photoacoustic and Kent imaging devices that can image vasculature and assess tissue perfusion on the foot.
| Study group | Role | What they receive |
|---|---|---|
| Single study arm | Experimental | Participants will undergo imaging using the investigational photoacoustic device. Receives: Device: Photoacoustic imaging and multispectral imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment fidelity rate
The ratio of cases received additional clinical assessment due to photoacoustic imaging results.
Measured: 12 months
Percentile healing score
The healing score will be defined as the ratio of the healed wound area versus the pre-treatment wound area (1-(post-treatment wound area)/(pre-treatment wound area)). A percentile healing value of 100% indicates that the wound is fully healed, while a value of 0% indicates that the wound area does not change.
Measured: 12 months
Secondary outcomes (1)
Recruitment rate
The ratio of recruited patients to the total number of eligible patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start28 Oct 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot UlcerStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Principal investigator, Jun Xia, Ph.D., State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216599
- Sponsor's protocol ID
- STUDY00009530
- Other IDs
- 5R01EB028978-04
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photoacoustic Imaging in Wound Evaluation and Treatment Guidance
- ClinicalTrials.gov ID
- NCT07216599
- Acronym / sponsor ID
- STUDY00009530
- Conditions
- Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Oct 2025 (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.
This pilot device trial aims to test the feasibility of using photoacoustic images to monitor tissue perfusion and to guide post-surgical wound treatment. Through this pilot study, the investigators will test the feasibility, identify any practical issues, and acquire essential information (e.g., drop-off rate, variation in wound healing rate) to guide future large-scale studies.
Detailed description
This pilot device trial aims to test the feasibility of using photoacoustic images to monitor tissue perfusion and to guide post-surgical wound treatment. Through this pilot study, the investigators will test the feasibility, identify any practical issues, and acquire essential information (e.g., drop-off rate, variation in wound healing rate) to guide future large scale studies.
For recruited patients, wound care will be guided by both photoacoustic imaging and Kent imaging, a multi-spectral imaging technique for tissue oxygenation mapping. None of the techniques is currently used in the clinic as standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single study arm | Experimental | Device: Photoacoustic imaging and multispectral imagingParticipants will undergo imaging using the investigational photoacoustic device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a chronic wound on the foot that is presumed to be due to arterial insufficiency.
Key exclusion criteria (5 listed)
- Patients with a massive deep tissue infection.
- Patients with preexisting skin conditions, such as melanoma, psoriasis, in areas close to the wound(s).
- Noncompliant patients who do not adhere to care plans.
- Pregnant women.
- Adults unable to consent.
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 imaging and multispectral imagingUse photoacoustic and Kent imaging devices that can image vasculature and assess tissue perfusion on the foot. | Device | Single study arm |
Primary outcome
Treatment fidelity rate
Time frame: 12 months
The ratio of cases received additional clinical assessment due to photoacoustic imaging results.
Percentile healing score
Time frame: 12 months
The healing score will be defined as the ratio of the healed wound area versus the pre-treatment wound area (1-(post-treatment wound area)/(pre-treatment wound area)). A percentile healing value of 100% indicates that the wound is fully healed, while a value of 0% indicates that the wound area does not change.
1 secondary outcome
Recruitment rate
Time frame: 12 months
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 30 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Photoacoustic imaging and multispectral imaging in people with Foot Ulcer, run by State University of New York at Buffalo at 1 site in United States.
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 1 inclusion and 5 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 30 Oct 2025. 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 United States. 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 Jun Xia, Ph.D. (716-645-8628, junxia@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment fidelity rate (time frame: 12 months). The study lists 2 primary outcomes in all. 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 30 Oct 2025.