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NCT Number: NCT07216599

Photoacoustic Imaging of Foot Wound

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.

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Key information

Conditions

Foot Ulcer Foot Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UBMD Vascular Surgery

Buffalo, New York, 14221, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a chronic wound on the foot that is presumed to be due to arterial insufficiency.

Exclusion criteria

  • 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.

Treatment and study plan

Photoacoustic imaging and multispectral imaging

Device

Use photoacoustic and Kent imaging devices that can image vasculature and assess tissue perfusion on the foot.

Primary outcomes

  1. Treatment fidelity rate

    Time frame: 12 months

    The ratio of cases received additional clinical assessment due to photoacoustic imaging results.

  2. 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.

Secondary outcomes

  1. Recruitment rate

    Time frame: 12 months

    The ratio of recruited patients to the total number of eligible patients

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Xia, Ph.D.

CONTACT

[email protected]

716-645-8628

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Registry information

Official study title

Photoacoustic Imaging in Wound Evaluation and Treatment Guidance

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 14, 2025
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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