Diabetic Neuropathy PeripheralAFOOTNCT03907189
Ambulation as a Factor on Oscillating Thermometry
An observational study of Diabetic Neuropathy Peripheral, run by Podimetrics, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathy Peripheral
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2019to 10 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Be at least 18 years old
- Not be pregnant
- Provide informed consent
- Have a prescription for monitoring with Podimetrics Remote Temperature Monitoring System
Who cannot join
- Be younger than 18 years old
- Unable to understand English
- Unable to provide consent
- At the discretion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetic Neuropathy Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start25 Mar 2019
- Primary completion10 Dec 2020 (estimated)
- Study completion10 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Neuropathy PeripheralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Podimetrics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Petersen, MS,MBA, Principal investigator, Podimetrics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907189
- Sponsor's protocol ID
- PCRT-0054P
- Acronym
- AFOOT
- Status last verified
- Apr 2020
- First submitted
- 26 Mar 2019
- Last updated
- 9 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulation as a Factor on Oscillating Thermometry
- ClinicalTrials.gov ID
- NCT03907189
- Acronym / sponsor ID
- AFOOT / PCRT-0054P
- Conditions
- Diabetic Neuropathy Peripheral
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Podimetrics, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 10 Dec 2020 (estimated)
- Study completion
- 10 Dec 2020 (estimated)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Be at least 18 years old
- Not be pregnant
- Provide informed consent
- Have a prescription for monitoring with Podimetrics Remote Temperature Monitoring System
Key exclusion criteria (4 listed)
- Be younger than 18 years old
- Unable to understand English
- Unable to provide consent
- At the discretion of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcome
Correlation of foot temperature data and daily activity in patients without inflammation to the plantar foot.
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Petersen, MS,MBA principal investigator
Podimetrics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Neuropathy Peripheral, run by Podimetrics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of foot temperature data and daily activity in patients with emergent inflammation. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.