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临床试验/NCT03046628
NCT03046628Unknown不适用

A Feasibility Study of Using Technology Based on Polarized Laser Light and Speed Camera for Non-invasive Tissue Perfusion Assessment of the Lower Extremities

Meir Medical Center0 个研究点目标入组 30 人开始时间: 2017年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
Correlation between TcPO2 results and reflected secondary speckle patterns

研究概览

简要总结

The aim of this study is to test the feasibility of using polarised green laser and CMOS camera in order to assess the tissue perfusion of lower extremity ulcers in patients suffering from diabetic foot by comparing this method with the percutaneous tissue oxygen tension examination which is currently the "gold standard" examination.

详细描述

An objective assessment of blood supply and oxygen delivery to the damaged tissue in patients with diabetic ulcer is very problematic with various currently accepted auxiliary examinations. These tests include measuring blood pressure ratio between the ankle or toes arm (ABI \ TBI), Sonar Doppler examination of the lower limb arteries, and percutaneous tissue oxygen tension examination (TcPO2). Each of these tests, along with the obvious advantages esprit ability to assess a non-invasive blood as number of disadvantages.

As the blood supply to the tissue is the most important healing of the tissue regardless of the type of intervention chosen (conservative treatment includes systemic antibiotics or surgical debridement), there is clear necessity for a non-invasive test with high reliably assessing tissue perfusion in patients with diabetic ulcers.

Recently, a new a method for assessing multiple features in vital tissues using polarised laser light was introduced. The technique is based on tracking temporal changes of reflected secondary speckles produced in the skin when being illuminated by a laser beam. Change in skin's temporal vibration profile is generated by time varied oxygen concentration caused these temporal changes. This technology of nanometer motion sensing allows, according to studies already carried out, monitoring parameters such as blood pressure, pulse rate and heart rhythm, glucose concentration in the blood substances and alcohol, oxygen saturation and intraocular pressure.

In this study the investigators will examine, non-invasively, the tissue around the lower limb ulcers of 30 diabetic patients, beginning with the TcPO2 examination followed by the polarised laser light and complementary metal-oxide semiconductor (CMOS) camera examination, and analysing the data in order to determine the ability of the latter method for assessing the tissue oxygen pressure.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients suffering from chronic diabetic ulcers

排除标准

  • Patients after amputation of some part in the lower limb
  • Patients with acute infection on bony involvement

结局指标

主要结局

Correlation between TcPO2 results and reflected secondary speckle patterns

时间窗: through study completion, an average of 1 year

recording and comparing between the examinations of each diabetic ulcer

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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