Ambulation as a Factor on Oscillating Thermometry

Diabetic Neuropathy Peripheral Clinical Trial

— AFOOT  

Official title:

Ambulation as a Factor on Oscillating Thermometry

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03907189
• Other study ID #: PCRT-0054P
• Status: Enrolling by invitation
• Start date: March 25, 2019
• Est. completion date: December 10, 2020

Study information

• Verified date: April 2020
• Source: Podimetrics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 10, 2020
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy Peripheral
• Peripheral Nervous System Diseases

Locations

Country	Name	City	State
United States	Podimetrics,Inc.	Somerville	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Podimetrics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Usage rate for Podimetrics Mat	The objective is to record the number of distinct days on which subject uses Podimetrics Mat for thermometry reading.	1 month
Other	Usage rate for the activity monitor	The objective is to record the percentage of time the subject uses the activity monitor.	1 month
Primary	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	Correlation of foot temperature data and daily activity in patients without inflammation to the plantar foot.	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