Clinical Utility of SUDOSCAN in the Pediatric Population

November 7, 2014 updated by: Impeto Medical

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

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California's Childhood Obesity Research Center (CORC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

100 subjects will be recruited by age group, with approximately 10 subjects representative of each age between 8 and 17. Both lean and obese subjects will be included from University of Southern California's Childhood Obesity Research Center (CORC).

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of participants with abnormal SUDOSCAN electrochemical skin conductance scores
Time Frame: Baseline
  • Sweat gland function will be assessed within each age group
  • Correlation with parameters associated with pre-diabetes and diabetes
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Impeto Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

August 7, 2014

First Submitted That Met QC Criteria

August 11, 2014

First Posted (Estimate)

August 13, 2014

Study Record Updates

Last Update Posted (Estimate)

November 11, 2014

Last Update Submitted That Met QC Criteria

November 7, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Impeto-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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