Study to Use Change in Near Infrared Spectroscopy Assessment of Tissue Oxygenation During a Provocative Leg Maneuver to Assess Peripheral Artery Disease State.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Comparing change in plantar foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test to the SOC clinical assessment of PAD
研究概览
简要总结
The objective of this trial is to determine if Near-infrared spectroscopy (NIRS) can accurately evaluate the degree of Peripheral Arterial Disease (PAD) during a Provocative Elevation Maneuver of the Lower Extremity (PEMLE) test, as compared to routine clinical assessments.
详细描述
This study is designed as a prospective observational study to assess the effectiveness of NIRS to accurately evaluate the degree of PAD, as compared to routine clinical assessment, during the PEMLE test protocol. This will be a single visit study where subjects will be screened and enrolled during a regular clinic visit.
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
- 35 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •35-99 years of age
- •Subject has at least 1 intact forefoot
- •Can achieve leg positions to complete the study
排除标准
- •The subject is unwilling or unable to comply with the protocol or scheduled appointments.
- •The subject has had transmetatarsal amputation or higher on both limbs.
- •Vascular intervention within the past year
- •Subjects who have had a previous distal bypass procedure
- •Pregnant or plans to become pregnant
- •Deemed by the PI to be unsuitable for the study
结局指标
主要结局
Comparing change in plantar foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test to the SOC clinical assessment of PAD
时间窗: 1-2 days
The significance of the relationship will be evaluated using an analysis of variance (ANOVA) where the independent variable will be the SOC assessment of PAD and the dependent variable will be the difference in NIRS measurement between the initial position (supine) and the second position (elevated leg).
次要结局
- Comparing change in plantar foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test paired with the presence/absence of diabetes to the SOC clinical assessment of PAD(1-2 days)
- Comparing change in dorsal foot NIRS measurements (baseline vs raised position) during a Provocative Maneuver Leg Raise test to the SOC clinical assessment of PAD(1-2 days)
- Change of NIRS measurements with other positions(1-2 days)