Photoacoustic Imaging in Wound Evaluation and Treatment Guidance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Treatment fidelity rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a chronic wound on the foot that is presumed to be due to arterial insufficiency.
排除标准
- •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.
研究组 & 干预措施
Single study arm
Participants will undergo imaging using the investigational photoacoustic device.
干预措施: Photoacoustic imaging and multispectral imaging (Device)
结局指标
主要结局
Treatment fidelity rate
时间窗: 12 months
The ratio of cases received additional clinical assessment due to photoacoustic imaging results.
Percentile healing score
时间窗: 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.
次要结局
- Recruitment rate(12 months)
研究者
Jun Xia, Ph.D.
Principal Investigator
State University of New York at Buffalo