Accuracy of Transcutaneous Oxygen Monitoring (TCOM) vs Near Infrared Spectroscopy (NIRS) in Predicting Wound Outcomes in Patients Treated With or Without Revascularization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Accuracy of NIRS measurements
研究概览
简要总结
The primary purpose of this project is to compare the accuracy of transcutaneous oxygen monitoring and near infrared spectroscopy in assessing cutaneous oxygen levels in chronic wounds of patients following revascularization procedures as well as those with conservatively managed chronic wounds. This study will also compare the efficiency and practicality of both methods in guiding treatment decisions and management of these wounds.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are between the ages of 18-85
- •Presented with a non-healing lower extremity wound and have a Wagner classification for wound healing of grade 1 or 2
排除标准
- •Wagner grade 3-5
- •Congestive heart failure (CHF) with a left ventrical ejection fraction (LVEF) < 30%
- •Have had a below the knee drug eluting stent placed (paclitaxel is chemo, can make wounds worse)
结局指标
主要结局
Accuracy of NIRS measurements
时间窗: From presentation to wound healing or amputation (approximately 6 months at most)
To determine the accuracy of near infrared spectroscopy when compared to transcutaneous oxygen monitoring in assessing cutaneous oxygen levels and guiding treatment in patients with revascularized tissues or conservatively managed chronic wounds.
次要结局
未报告次要终点