Investigation of the Predictive Value of Near Infrared Spectroscopy in Chronic Lower Extremity and Other Chronic Non-healing Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 221
- 试验地点
- 5
- 主要终点
- Patient health outcome
研究概览
简要总结
Investigation of the predictive value of Near Infrared Spectroscopy in Chronic Lower Extremity and Other Chronic non-healing Ulcers
详细描述
The objective of this study is to evaluate the clinical and economical effect of introduction of near-infrared spectroscopy (NIRS) in the diagnostic and treatment protocol of patients with lower extremity (LE) ulcers as well as other chronic non-healing ulcers, and to determine a positive and/or negative predictive value or range of values for NIRS correlating to patient progress and outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Current patients or patients admitted to Christus Wound Care and Hyperbaric Medicine Departments between July 1, 2024, and December 31, 2024, for the treatment of lower extremity ulcers and other chronic non-healing ulcers.
- •Lower extremity ulcers and chronic non-healing ulcers will be included in the study regardless of the wound/ulcer etiology. Patients may become eligible for the study at any point during their course of treatment.
排除标准
- •Patients who are being treated at multiple research sites simultaneously.
结局指标
主要结局
Patient health outcome
时间窗: From enrollment to closeout or 12 weeks from enrollment whichever is earlier
To evaluate the impact of the addition of NIRS to the SOP on patient health outcome by comparing between the control and interventional groups
次要结局
- Health Economic Impact(From enrollment to closeout or 12 weeks from enrollment whichever is earlier)