NCT03907189

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 26, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2020

Completed
Last Updated

April 9, 2020

Status Verified

April 1, 2020

Enrollment Period

1.7 years

First QC Date

March 26, 2019

Last Update Submit

April 7, 2020

Conditions

Diabetic Neuropathy Peripheral

Outcome Measures

Primary Outcomes (1)

  • Correlation of foot temperature data and daily activity in patients with emergent inflammation.

    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 Outcomes (1)

  • Correlation of foot temperature data and daily activity in patients without inflammation to the plantar foot.

    1 month

Other Outcomes (2)

  • Usage rate for Podimetrics Mat

    1 month

  • Usage rate for the activity monitor

    1 month

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Be younger than 18 years old
  • Unable to understand English
  • Unable to provide consent
  • At the discretion of the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Podimetrics,Inc.

Somerville, Massachusetts, 02144, United States

Location

Study Officials

  • Brian Petersen, MS,MBA

    Podimetrics, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2019

First Posted

April 8, 2019

Study Start

March 25, 2019

Primary Completion

December 10, 2020

Study Completion

December 10, 2020

Last Updated

April 9, 2020

Record last verified: 2020-04

Locations

US(1)