Correlation Between FlowMet™, ABI, SPP, TBI, TcPO2 and Angiography
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Correlation between FlowMet perfusion values and ankle-brachial index and toe-brachial index in 34 patients who present to outpatient clinic.
研究概览
简要总结
The purpose of this study is to demonstrate the utility of the FlowMet™ device in the assessment of perfusion in subjects suspected of or being treated for critical limb ischemia, in comparison to other gold standard technologies, such as ankle brachial pulse index (ABI), skin perfusion pressure (SPP), toe brachial pulse index (TBI), transcutaneous oxygen tension (TcP02), and angiography currently in use in the clinic.
详细描述
TRIAL OBJECTIVES
1.0
To demonstrate that the FlowMet is effective for the assessment of tissue perfusion compared to gold standard technologies in patients suspected of or being treated for CLI.
2.0 STUDY DESIGN
This is a single center, cross-sectional study of subjects who are scheduled for CLI assessment with a Rutherford score of V and VI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Subject is willing and able to provide an informed consent.
- •Subject is willing and able to comply with the study procedures.
- •Subject is able to understand the study procedures.
- •Subject is being seen at the clinic for the evaluation/treatment of CLI.
- •Subject has a Rutherford score of V or VI.
排除标准
- •Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
- •Anyone with a latex allergy
- •Must be over 18 years old
- •Must not be pregnant during time of study
结局指标
主要结局
Correlation between FlowMet perfusion values and ankle-brachial index and toe-brachial index in 34 patients who present to outpatient clinic.
时间窗: One year
Correlation between FlowMet perfusion values evaluating the median systolic, median diastolic, and overall flow and amplitude as compared to ABI and TBI. This is a feasibility study to determine the degree of correlation between this novel device and current standard of care testing to see how the numerical values obtained correlate with both normal and abnormal values of well established testing. Normal values of ABI (ratios of \> 0.9 to \< 1.3) and TBI (ratios of \> 0.7).
Correlation between FlowMet perfusion values and skin perfusion pressure in 34 patients who present to outpatient clinic.
时间窗: One year
Correlation between FlowMet perfusion values evaluating the median systolic, median diastolic, and overall flow and amplitude as compared to skin perfusion pressure testing. This is a feasibility study to determine the degree of correlation between this novel device and current standard of care testing to see how the numerical values obtained correlate with both normal and abnormal values of well established testing. Normal values of SPP are 40-50 mmHg.
Correlation between FlowMet perfusion values and angiography in 34 patients who present to outpatient clinic.
时间窗: One year
Correlation between FlowMet perfusion values evaluating the median systolic, median diastolic, and overall flow and amplitude as compared to angiography. This is a feasibility study to determine the degree of correlation between this novel device and current standard of care testing to see how the numerical values obtained correlate with both normal and abnormal angiographic images as defined by severity of stenosis.
Correlation between FlowMet perfusion values and transcutaneous oxygen tension in 34 patients who present to outpatient clinic.
时间窗: One year
Correlation between FlowMet perfusion values evaluating the median systolic, median diastolic, and overall flow and amplitude as compared to transcutaneous oxygen testing. This is a feasibility study to determine the degree of correlation between this novel device and current standard of care testing to see how the numerical values obtained correlate with both normal and abnormal values of well established testing. Normal value at the foot is 40-50 mmHg.
次要结局
- Correlation between FlowMet perfusion values and Rutherford score(One year)
- Correlation between FlowMet perfusion values and time of surgical (re)admission(One year)
- Correlation between FlowMet perfusion values and speed of wound healing(One year)