Foot Ulcer
Conditions
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.
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
DEVICEPhotoacoustic imaging and multispectral imaging
Use photoacoustic and Kent imaging devices that can image vasculature and assess tissue perfusion on the foot.
Sponsors
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
State University of New York at Buffalo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment fidelity rate | 12 months | The ratio of cases received additional clinical assessment due to photoacoustic imaging results. |
| Percentile healing score | 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
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 12 months | The ratio of recruited patients to the total number of eligible patients |
Countries
United States
Contacts
Primary ContactJun Xia, Ph.D.
Outcome results
None listed