Photoacoustic Imaging of Foot Wound
Photoacoustic Imaging in Wound Evaluation and Treatment Guidance
2 other identifiers
interventional
25
1 country
1
Brief 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, variation in wound healing rate) to guide future large-scale studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2025
CompletedFirst Posted
Study publicly available on registry
October 14, 2025
CompletedStudy Start
First participant enrolled
October 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
October 30, 2025
October 1, 2025
11 months
October 2, 2025
October 29, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Treatment fidelity rate
The ratio of cases received additional clinical assessment due to photoacoustic imaging results.
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.
12 months
Secondary Outcomes (1)
Recruitment rate
12 months
Study Arms (1)
Single study arm
EXPERIMENTALParticipants will undergo imaging using the investigational photoacoustic device.
Interventions
Use photoacoustic and Kent imaging devices that can image vasculature and assess tissue perfusion on the foot.
Eligibility Criteria
You may qualify if:
- Patients with a chronic wound on the foot that is presumed to be due to arterial insufficiency.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UBMD Vascular Surgery
Buffalo, New York, 14221, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 2, 2025
First Posted
October 14, 2025
Study Start
October 28, 2025
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
October 30, 2025
Record last verified: 2025-10