Wound Assessment Using Spectral Imaging US
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 10
- 主要终点
- Data Collection
研究概览
简要总结
During the observational, non-interventional study, at Baseline Study Visit (BSV) subjects will be screened and consented. Eligible subjects will undergo imaging with the DeepView device. Pre- and post-debridement images will be obtained (if debridement performed per SOC), as well as reviewing medical history and physical assessments.
Additional Study Visits (SVs) will be performed when patient returns to the clinic for Routine Clinic Visit for up to 12 weeks or wound closure. During these visits DeepView imaging will occur pre- and post-debridement, and the status of the subject's treatment will be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •At least 18 years old.
- •Subject has an ulcer, or slow healing wound that is full thickness for at least 4 weeks, below the malleolus, in the presence of Diabetes.
- •The target ulcer will be the largest ulcer if two or more eligible DFUs are present and will be the only one evaluated in the study.
- •The target ulcer is planned to undergo standard wound care (SWC) therapy (See 8.6 Standard Wound Care (SWC) Therapy).
- •Subject understands and is willing to participate in the clinical study and can comply with required visits.
排除标准
- •Target ulcer is deemed by the investigator to be caused by a medical condition other than diabetes.
- •Target ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
- •Eligible DFU has associated untreated acute osteomyelitis or active infection
- •Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), or cytotoxic chemotherapy.
- •Subjects on any investigational drug(s) or device(s) within 30 days preceding initial study visit.
结局指标
主要结局
Data Collection
时间窗: 12 weeks
The purpose of this study is to build a database for development and validation of a machine learning (ML) algorithm for diabetic foot ulcer (DFU) healing assessment using images obtained with the Spectral MD DeepView device.
次要结局
未报告次要终点