AFOOT: Ambulation as a Factor on Oscillating Thermometry

Sponsor

Podimetrics, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03907189

Collaborator

(none)

100

Enrollment

Location

20.6

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Neuropathy Peripheral

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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Ambulation as a Factor on Oscillating Thermometry

Actual Study Start Date :

Mar 25, 2019

Anticipated Primary Completion Date :

Dec 10, 2020

Anticipated Study Completion Date :

Dec 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Emergent Inflammation Subjects with emergent inflammation detected by Podimetrics RTM Mat within the last week.
No Inflammation Subjects with no emergent inflammation detected by Podimetrics RTM Mat within the last week.

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Usage rate for Podimetrics Mat [1 month]
The objective is to record the number of distinct days on which subject uses Podimetrics Mat for thermometry reading.
Usage rate for the activity monitor [1 month]
The objective is to record the percentage of time the subject uses the activity monitor.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Podimetrics,Inc.	Somerville	Massachusetts	United States	02144

Sponsors and Collaborators

Podimetrics, Inc.

Investigators

Principal Investigator: Brian Petersen, MS,MBA, Podimetrics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Podimetrics, Inc.

ClinicalTrials.gov Identifier:

NCT03907189

Other Study ID Numbers:

PCRT-0054P

First Posted:

Apr 8, 2019

Last Update Posted:

Apr 9, 2020

Last Verified:

Apr 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Diabetic Neuropathies

Peripheral Nervous System Diseases

Study Results

No Results Posted as of Apr 9, 2020