Ambulation as a Factor on Oscillating Thermometry (AFOOT)

April 7, 2020 updated by: Podimetrics, Inc.
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

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
    • Massachusetts
      • Somerville, Massachusetts, United States, 02144
        • Podimetrics,Inc.

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study populations consists of patients at risk of diabetic foot ulcers and other inflammatory foot diseases with an existing prescription for monitoring with Podimetrics Remote Temperature Monitoring System.

Description

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 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

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of foot temperature data and daily activity in patients with emergent inflammation.
Time Frame: 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.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of foot temperature data and daily activity in patients without inflammation to the plantar foot.
Time Frame: 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.
1 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usage rate for Podimetrics Mat
Time Frame: 1 month
The objective is to record the number of distinct days on which subject uses Podimetrics Mat for thermometry reading.
1 month
Usage rate for the activity monitor
Time Frame: 1 month
The objective is to record the percentage of time the subject uses the activity monitor.
1 month

Collaborators and Investigators

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

Sponsor

Podimetrics, Inc.

Investigators

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

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 (Actual)

March 25, 2019

Primary Completion (Anticipated)

December 10, 2020

Study Completion (Anticipated)

December 10, 2020

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

April 5, 2019

First Posted (Actual)

April 8, 2019

Study Record Updates

Last Update Posted (Actual)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCRT-0054P

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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