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临床试验/NCT03144050
NCT03144050Unknown不适用

Optical Imaging For Assessment of Foot Perfusion

Modulated Imaging Inc.1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2017年4月14日最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
Clinical risk category

研究概览

简要总结

This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic.

详细描述

This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic. SFDI is a non-contact optical imaging technology that measures tissue functional (blood volume, tissue oxygen saturation) and structural information (scattering index) across a large field of view. Our hypothesis is that SFDI parameters can eventually become a quantitative tool to assess foot health and identify patients at risk for ulcer formation. This phase of the study is designed to correlate SFDI outputs to current clinical risk categories

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Pregnant/lactating women
  • Rheumatoid arthritis

结局指标

主要结局

Clinical risk category

时间窗: immediate

risk assessment based on clinical signs

次要结局

  • Ulcer incidence(1 year)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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