Ambulation as a Factor on Oscillating Thermometry

• Conditions: Diabetic Neuropathy Peripheral

• Registration Number: NCT03907189
• Lead Sponsor: Podimetrics, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-03-25
• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-08
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-09
• Primary Completion: 2020-12-10
• Study Completion: 2020-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Study subjects must

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of foot temperature data and daily activity in patients with emergent inflammation.	1 month	The primary objective of the study is to examine whether temperature data from subjects with inflammation to the plantar foot as determined by the Podimetrics RTM System is correlated with activity as measured by the activity monitor.

Secondary Outcome Measures

Name	Time	Method
Correlation of foot temperature data and daily activity in patients without inflammation to the plantar foot.	1 month	The secondary objective of the study is to examine whether temperature data from patients without inflammation to the plantar foot as determined by the Podimetrics RTM System is correlated with subject activity as measure by the activity monitor.

Trial Locations

Locations (1)

Podimetrics,Inc.; 🇺🇸 Somerville, Massachusetts, United States