Health TrialsbyHealthPanel

Photoacoustic Imaging of Foot Wound

ConditionFoot Ulcer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorState University of New York at Buffalo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Photoacoustic imaging and multispectral imaging

    Device

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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Single study armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Treatment fidelity rate

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

Time frame
12 months
2

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.

Time frame
12 months

Secondary outcomes

1

Recruitment rate

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

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

State University of New York at Buffalo

Lead sponsor

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Source ClinicalTrials.gov
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