Ambulation as a Factor on Oscillating Thermometry

NCT ID: NCT03907189

Last Updated: 2020-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-25

Study Completion Date

2020-12-10

Brief Summary

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This research study aims to better understand how the plantar temperature data collected by the Podimetrics RTM System corresponds to physical activity level in subjects.

Detailed Description

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Subjects with prescription for monitoring with Podimetrics RTM System will be assigned activity monitors to track physical activity. Data from the Podimetrics RTM System and the activity monitor will be assessed after one month of use to determine any correlation between the two data sets and adherence to the use of activity monitor.

Conditions

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Diabetic Neuropathy Peripheral

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Emergent Inflammation

Subjects with emergent inflammation detected by Podimetrics RTM Mat within the last week.

No interventions assigned to this group

No Inflammation

Subjects with no emergent inflammation detected by Podimetrics RTM Mat within the last week.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Be at least 18 years old
* Not be pregnant
* Provide informed consent
* Have a prescription for monitoring with Podimetrics Remote Temperature Monitoring System

Exclusion Criteria

* Be younger than 18 years old
* Unable to understand English
* Unable to provide consent
* At the discretion of the investigator
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Podimetrics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian Petersen, MS,MBA

Role: PRINCIPAL_INVESTIGATOR

Podimetrics, Inc.

Locations

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Podimetrics,Inc.

Somerville, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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PCRT-0054P

Identifier Type: -

Identifier Source: org_study_id

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