Recruiting

Observational Study

Sponsor:

State University of New York at Buffalo

Code:

NCT07216599

Conditions

Foot Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Photoacoustic imaging and multispectral imaging

Study Details

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.

Conditions

Foot Ulcer

Study ID

NCT07216599

Start date

Oct 28, 2025

Status verified date

Oct, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single study arm

Participants will undergo imaging using the investigational photoacoustic device.

Interventions

Photoacoustic imaging and multispectral imaging

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

Primary outcome measure

  • Treatment fidelity rate [ Time Frame: 12 months ]
  • Percentile healing score [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Jun Xia, Ph.D.

716-645-8628junxia@buffalo.edu

Locations

UBMD Vascular Surgery

Recruiting

Buffalo, New York, United States, 14221

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2025-10-30.