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Recruiting NCT07216599

Photoacoustic Imaging of Foot Wound

No phase Interventional Foot Ulcer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Photoacoustic imaging and multispectral imaging.
Who it may be relevant to
Registry conditions: Foot Ulcer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Photoacoustic Imaging in Wound Evaluation and Treatment Guidance

Overview

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.

Interventions

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

Primary outcome measures

  • Treatment fidelity rate [Time frame: 12 months]
  • Percentile healing score [Time frame: 12 months]
Secondary outcome measures (1)
  • Recruitment rate [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • UBMD Vascular Surgery — Buffalo

Identifiers

NCT: NCT07216599 · STUDY00009530 · 5R01EB028978-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗