Photoacoustic Imaging of Foot Wound

NCT ID: NCT07216599

Last Updated: 2025-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-28

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Foot Ulcer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single study arm

Participants will undergo imaging using the investigational photoacoustic device.

Group Type EXPERIMENTAL

Photoacoustic imaging and multispectral imaging

Intervention Type DEVICE

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

Interventions

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Photoacoustic imaging and multispectral imaging

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Jun Xia, Ph.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UBMD Vascular Surgery

Buffalo, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jun Xia, Ph.D.

Role: CONTACT

716-645-8628

Other Identifiers

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5R01EB028978-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00009530

Identifier Type: -

Identifier Source: org_study_id

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