跳至主要内容
临床试验/NCT02216201
NCT02216201撤回不适用

Clinical Utility of SUDOSCAN in the Pediatric Population

Impeto Medical1 个研究点 分布在 1 个国家开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Identification of participants with abnormal SUDOSCAN electrochemical skin conductance scores

研究概览

简要总结

The main purpose of this study is to evaluate whether SUDOSCAN is a valid, accurate clinical device for the the determination of sweat gland function in the pediatric population.

Primary Objective: To measure sweat gland function in a pediatric population

Secondary Objective: To determine thresholds on the SUDOSCAN scale for abnormal sweat gland function in the pediatric population

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
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Males and females ages 8 to 17 years
  • Able to give assent as well as parental consent

排除标准

  • History of type 1 or type 2 diabetes
  • Chronic autoimmune condition
  • Taking chronic immunosuppressive or anti-inflammatory medications
  • Unable to apply palms of the hands and soles of the feet on the sensor plates during a 3 minute Sudoscan test
  • Presence of hepatitis B or C
  • Presence of HIV
  • Presence of known neurological disorder
  • Pregnancy and/or breastfeeding
  • Any open wound on the soles of the feet or palms of the hands
  • Participation in an ongoing clinical investigational drug trial
  • Other serious medical conditions that in the opinion of the investigator, would compromise the subject's participation in the study

结局指标

主要结局

Identification of participants with abnormal SUDOSCAN electrochemical skin conductance scores

时间窗: Baseline

* Sweat gland function will be assessed within each age group * Correlation with parameters associated with pre-diabetes and diabetes

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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