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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Usage rate for the activity monitor | The objective is to record the percentage of time the subject uses the activity monitor. |
Inclusion Criteria: Study subjects must
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Brian Petersen, MS,MBA | Podimetrics, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Podimetrics,Inc. | Somerville | Massachusetts | 02144 | United States |
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| 1 month |