Ambulation as a Factor on Oscillating Thermometry (AFOOT)

Podimetrics

Status: Unknown

Conditions: Diabetic Neuropathy Peripheral

Study type: Observational

Funder types: Industry

Identifiers

NCT03907189

PCRT-0054P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

100 participants in 2 patient groups

Emergent Inflammation

Description:

Subjects with emergent inflammation detected by Podimetrics RTM Mat within the last week.

No Inflammation

Description:

Subjects with no emergent inflammation detected by Podimetrics RTM Mat within the last week.