NCT04630704Unknown不适用
A Feasibility Study Evaluating A Non-Invasive Tissue Perfusion Monitor Utilising Diffuse Speckle Contrast Analysis
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- The Blood Perfusion Index (unitless number) delta in response to reduction in arterial inflow pressure
研究概览
简要总结
The Pedra perfusion system will be used to assess changes in perfusion in response to physiological stimuli. It will be compared to other standard diagnostics.
详细描述
The Pedra perfusion system measures microvascular flow through diffuse speckle contrast analysis. It will be used to assess changes in perfusion in response to a number of physiological stimuli. It will be compared to other standard diagnostics including ankle-brachial index, toe-brachial index and transcutaneous oxygen measurement. Measurements will be undertaken in non-vascular patients as well as those with chronic limb threatening ischaemia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CLTI cohort
- •At least 40 years old
- •Each patient will have documented arterial occlusive disease within 6 weeks of enrolment as determined by an ankle-brachial index (ABI) < 0.7 but not greater than 1.2, toe-brachial index (TBI) <0.5, skin perfusion pressure (SPP) less than 30mmHg, OR Transcutaneous oxygen measurement (TCOM) < 40mmHg in diabetics and <30mmHg in non-diabetics.
- •The presence of skin breakdown compatible which with an underlying ischemic element (previous minor amputation for gangrene also included) that the Principle Investigator (PI) deems appropriate for the study.
- •Subject has read, understood and signed approved consent, and is willing to participate and comply with the study procedures and requirements.
- •Non-vascular group
- •At least 40 years old
- •Each patient will have documented palpable foot pulses
- •21 patients will be free of lower limb oedema and 6 patients will have moderate oedema present
- •Subject has read, understood and signed approved consent, and is willing to participate and comply with the study procedures and requirements.
排除标准
- •CLTI Cohort
- •Subject on an investigational drug or therapeutic device within 30 days of the study visit, which in the view of the PI may compromise the study results.
- •Presence of a condition that PI considers will compromise the subject's ability to participate in the study.
- •Age <40 or >90
- •Inability to straight leg raise to 30 degrees or tolerate calf cuff occlusion.
- •Has smoked cigarettes/e-cigarettes on the day of testing.
- •Has taken caffeine drinks on the day of testing
- •In the last 3 hours the subject has exercised beyond normal daily walking.
- •Inability to have TBI measured (e.g. absence of toe)
- •Signs of active infection causing localised inflammation on the plantar or dorsal surfaces of the foot
- •Pathological skin conditions that may impair the ability of the adhesive sensor pads to adhere.
- •Non-vascular Cohort
- •Subject on an investigational drug or therapeutic device within 30 days of the study visit, which in the view of the PI may compromise the study results.
- •Presence of a condition that PI considers will compromise the subject's ability to participate in the study.
- •Age <40 or >90
- •Inability to straight leg raise to 30 degrees or tolerate calf cuff occlusion.
- •Has smoked cigarettes/e-cigarettes on the day of testing.
- •Has taken caffeine drinks on the day of testing
- •In the last 3 hours the subject has exercised beyond normal daily walking.
- •Inability to have TBI measured (e.g. absence of toe)
- •Signs of active infection causing localised inflammation on the plantar or dorsal surfaces of the foot
- •Pathological skin conditions that may impair the ability of the adhesive sensor pads to adhere.
结局指标
主要结局
The Blood Perfusion Index (unitless number) delta in response to reduction in arterial inflow pressure
时间窗: Intra-procedure
The range of change in the Blood Perfusion Index (unitless) in response to physiologic changes in arterial perfusion, in patients with healthy circulation and those with compromised arterial circulation
次要结局
- Sensitivity of Pedra to detect differences in the Blood Perfusion Index between patient subsets(Intra-procedure)
- Reliability of Blood Perfusion Index measurement will be assessed on repeated measures by determination of the correlation coefficient(intra-procedure)
- Repeatability of Blood Perfusion Index measurement will be assessed on repeated measures by determination of the correlation coefficient(intra-procedure)
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