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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01EB028978-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single study arm | Experimental | Participants will undergo imaging using the investigational photoacoustic device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photoacoustic imaging and multispectral imaging | Device | Use photoacoustic and Kent imaging devices that can image vasculature and assess tissue perfusion on the foot. |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment fidelity rate | The ratio of cases received additional clinical assessment due to photoacoustic imaging results. | 12 months |
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | The ratio of recruited patients to the total number of eligible patients | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Xia, Ph.D. | Contact | 716-645-8628 | junxia@buffalo.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UBMD Vascular Surgery | Recruiting | Buffalo | New York | 14221 | United States |
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| ID | Term |
|---|---|
| D016523 | Foot Ulcer |
| ID | Term |
|---|---|
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007871 | Leg Ulcer |
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| D012883 |
| Skin Ulcer |