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临床试验/NCT02798640
NCT02798640已完成不适用

A Single Center Prospective Comparative Study to Evaluate the Performance of a Upper Torso Garment Containing 100% Celliant Fibers That Emits Far Infrared (FIR) From Ceramic Particles Contained Within the Fibers in Healthy Subjects

Kristopher Washington2 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2013年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
153
试验地点
2
主要终点
Changes in transcutaneous oxygen tension (tcPO2)

研究概览

简要总结

The study will evaluate changes in transcutaneous oxygen tension (tcPO2,), and the inferred change in local cutaneous blood flow, in healthy subjects wearing a control and a 100% Celliant® fiber upper torso garment.

详细描述

Adequate blood supply is necessary for many physiologic processes. However, there are few valid, reproducible, non-invasive methods with which to assess it. One such measure is transcutaneous partial pressure of oxygen (tcPO2). This measurement is a non-invasive method of measuring oxygen tension at the skin surface; represents the amount of oxygen diffusing outward across the skin; and can be used as a surrogate for arterial perfusion. This method is reproducible with clinically acceptable intrasubject variability; is used for a variety of conditions, including peripheral vascular disease evaluation, predicting the outcome of patients requiring amputation and survival of skin grafts; and correlates well to angiography and increases in blood flow rates. However, tcPO2 is affected by many variables, including oxygen concentration in inspired air, lung function and hemoglobin saturation, as well as local factors, such as skin thickness, sympathetic tone, the presence of inflammation, capillary formation and skin oxygen consumption.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects greater than or equal to18 years of age
  • Men and women between the ages of 18 and 60 years
  • Able to understand and consent to the study
  • Able to follow directions of the Study Coordinators and/or the Principal Investigator
  • Able to complete the study
  • Male or female subjects of any ethnic origin such that the balance across ages and among population groups is reflective of the site population

排除标准

  • Active smokers
  • No history of cardiovascular disease
  • No history of peripheral vascular disease
  • Engaged in recreational drug use for the six months prior to the start of the study
  • Eaten within two (2) hours of the study
  • Consumed caffeine within four (4) hours prior to the study
  • Consumed alcohol with forty-eight (48) hours prior to the study
  • Subjects with any unstable medical or psychiatric problem
  • Subjects who are pregnant or nursing mothers
  • Subjects who are currently taking part in another clinical study or have taken part in a drug or device study, in the past month.

结局指标

主要结局

Changes in transcutaneous oxygen tension (tcPO2)

时间窗: 0,30,60,90 minutes

comparison of individual measurements taken at these time points

次要结局

  • Changes in local skin temperature by infrared imaging(0,30,60,90 minutes)

研究者

发起方
Kristopher Washington
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Kristopher Washington

Study Coordinator

Hologenix, LLC

研究点 (2)

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