Diabetic FootSTOPNCT05728411
Effectiveness of Remote Foot Temperature Monitoring
A study testing Remote foot temperature monitoring system in people with Diabetic Foot, run by VA Office of Research and Development at 4 sites in United States.
Trial summary
Diabetic foot ulcers are common, debilitating, and costly complications of diabetes, disproportionately impacting Black and rural Veterans. Forty percent of individuals have an ulcer recurrence within a year of ulcer healing and 65% within 5 years. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Remote foot temperature monitoring system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 379 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Oct 2023to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran
- Diabetes diagnosis
- History of foot ulcer (including active ulcer) OR history of lower extremity amputation (including unhealed amputation)
- Able to understand/read English
Who cannot join
- Dementia
- Unable to ambulate
- Bilateral lower extremity amputation
- Ankle brachial index <0.6 or toe brachial index <0.5
- Currently using in-home temperature monitoring
- Prisoner
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
Richmond VA Medical Center, Richmond, VA
Richmond, Virginia, 23249-0001
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
Spokane VA Medical Center, Spokane, WA
Spokane, Washington, 99205-6185
About this study
Official title: Home Foot-temperature Monitoring Through Smart Mat Technology to Improve Access, Equity, and Outcomes in High-risk Patients With Diabetes
Diabetic foot ulcers are common, debilitating, and costly complications of diabetes, disproportionately impacting Black and rural Veterans. Forty percent of individuals have an ulcer recurrence within a year of ulcer healing and 65% within 5 years. Monitoring plantar foot temperatures is one of the few interventions that reduces the risk of ulcer recurrence. Despite the evidence, adoption has been poor because the original procedures, including the use of handheld thermometers, were burdensome and time-consuming. Podimetrics, a private company, has developed a temperature monitoring system involving a "smart" mat that can wirelessly transmit data and a remote monitoring team that works with VA providers to assist with triage and monitoring. This care model has incredible promise, but has been untested in VA. The investigators propose to conduct a randomized trial to evaluate effectiveness of remote temperature monitoring as well as costs. Additionally, the investigators will evaluate the implementation process, including barriers and facilitators to use among key stakeholders.
Read the detailed description
Objective(s) and Hypotheses: Diabetic foot ulcers (DFU) are common, debilitating, and costly complications of diabetes, disproportionately impacting Black and rural Veterans. Forty percent of individuals have an ulcer recurrence within a year of ulcer healing and 65% within 5 years. Remote temperature monitoring (RTM) of feet is one of the few interventions that reduces the risk of ulcer recurrence. Despite the evidence, adoption has been poor because the original procedures, including the use of handheld thermometers, were burdensome and time-consuming. Podimetrics, a private company, has developed a temperature monitoring system involving a "smart" mat that measure foot temperatures and a remote monitoring team that works with VA providers to assist with triage and monitoring. This care model has incredible promise, but has been untested in VA.
The specific aims of this study are to: 1) Evaluate the effectiveness of RTM vs. usual care in terms of primary (ulceration) and secondary outcomes (severity of ulceration, amputation, hospitalization, emergency room visits, quality of life, satisfaction with care, and self-efficacy for managing diabetes) at 6, 12, 18, and 24 months; 2) Collect data on costs of RTM and compare with usual care costs, if effectiveness is demonstrated; and 3) Evaluate the implementation process, including barriers and facilitators to use among key stakeholders
Research Design: For Aim 1, the investigators will conduct a multi-site randomized controlled study. Aim 2 involves a budget impact analysis to evaluate costs of RTM. Aim 3 involves qualitative interviews to understand barriers and facilitators to implementation of RTM.
Methodology: For Aim 1, the investigators will aim to enroll at least 406 patients who have had a history of DFU or amputation (including active ulcers). Patients will be randomized 1:1 to RTM or usual care (no RTM), with randomization stratified on site and active ulcer vs. not. For Aim 2, the investigators will collect data and observe providers to quantify provider time for selecting patients for RTM, ordering mats, and responding to alerts of "hot spots". The investigators will use medical records to assess patient utilization (ulcer/amputation-related outpatient, inpatient, and emergency room visits) and associated costs of care for patients in the RTM and comparison groups. For Aim 3, the investigators will conduct semi-structured phone interviews with 30-50 Veterans and 12-30 providers and use the Consolidated Framework for Implementation Research to guide data collection and analysis.
Relevance to VA Mission: Findings from this study will be used to inform effective, efficient, and equitable scaling of RTM in VA.
- Conditions
- Diabetic Foot
- Being tested
- Remote foot temperature monitoring system, Enhanced usual care
- Keywords
- diabetic foot, remote sensing technology, Department of Veterans Affairs
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote foot temperature monitoring systemOther
Remote temperature monitoring involves a thermometric mat that can detect "hot spots" on the plantar surface of the foot. The mat has embedded cellular connectivity so that data can be transmitted from the patient's home to the company, where the temperature data can be analyzed. The company has a team of health coaches that work with patients and providers to detect signs of damage early in order to prevent ulceration.
Enhanced usual careOther
Usual care is based on the VA's amputation prevention program (PAVE - Preventing Amputation in Veterans Everywhere - VHA Directive 1410), which provides a model of care for patients at risk for amputation as well as patients who have already undergone an amputation.
Usual care will be enhanced by providing resources (e.g., information through written newsletters) relevant to a population of Veterans with diabetes, including information on nutrition and cooking, physical activities, and whole health opportunities
| Study group | Role | What they receive |
|---|---|---|
| Remote temperature monitoring + enhanced usual care | Experimental | Enrollment in remote foot temperature monitoring in addition to enhanced usual care (described below) Receives: Other: Remote foot temperature monitoring system; Other: Enhanced usual care |
| Enhanced usual care | Other | Usual care is based on the VA's amputation prevention program (PAVE - Preventing Amputation in Veterans Everywhere - VHA Directive 1410), which provides a model of care for patients at risk for amputation as well as patients who have already undergone an amputation.
Usual care will be enhanced by providing resources (e.g., information through written newsletters) relevant to a population of Veterans with diabetes, including information on nutrition and cooking, physical activities, and Whole Health opportunities Receives: Other: Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of foot ulceration
The primary outcome is the presence of new ulceration through 24 months
Measured: 24 months
Secondary outcomes (4)
Rate of lower limb amputation
Any level of lower extremity amputation
Measured: 24 months
Mean or median quality of life scores
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health v1.2. The global scale produces two scores: Global Mental Health and Global Physical Health. Raw scores are converted to T-score values (higher values indicate better health). Minimum and maximum T scores for Global Mental Health are 21.2 and 67.6, respectively. Minimum and maximum T scores for Global Physical Health are 16.2 and 67.7, respectively.
Measured: 6,12, 18 and 24 months
Mean or median satisfaction with care scores
Short assessment of patient satisfaction (SAPS) by Hawthorne G et al (2006) which includes 7 items. Each item is scored on a 0 to 4 scale. The score range is from 0 (extremely dissatisfied) to 28 (extremely satisfied).
Measured: 6,12, 18 and 24 months
Mean or median self-efficacy for diabetes
8-item Self-efficacy for diabetes measure that has a range of 1 to 10. Higher scores indicate higher self-efficacy.
Measured: 6, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start2 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alyson J. Littman, PhD MPH, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728411
- Sponsor's protocol ID
- IIR 21-176
- Acronym
- STOP
- Status last verified
- Jul 2026
- First submitted
- 3 Feb 2023
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Subject to IRB approval, de-identified data will be released to a local VAPSHCS and/or national VA research data repository for release to non-VA protocols. The VA research data repository administrator will be responsible for reviewing and responding to requests to release data to non-VA requesters. A data use agreement compliant with VHA Handbooks 1200.12 and 1605.1 will be required between VHA and the requester. Review and approval by VA privacy officer is required prior to disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Foot-temperature Monitoring Through Smart Mat Technology to Improve Access, Equity, and Outcomes in High-risk Patients With Diabetes
- ClinicalTrials.gov ID
- NCT05728411
- Acronym / sponsor ID
- STOP / IIR 21-176
- Conditions
- Diabetic Foot
- Keywords
- diabetic foot, remote sensing technology, Department of Veterans Affairs
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 379 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 15 Feb 2023 (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.
Diabetic foot ulcers are common, debilitating, and costly complications of diabetes, disproportionately impacting Black and rural Veterans. Forty percent of individuals have an ulcer recurrence within a year of ulcer healing and 65% within 5 years. Monitoring plantar foot temperatures is one of the few interventions that reduces the risk of ulcer recurrence. Despite the evidence, adoption has been poor because the original procedures, including the use of handheld thermometers, were burdensome and time-consuming. Podimetrics, a private company, has developed a temperature monitoring system involving a "smart" mat that can wirelessly transmit data and a remote monitoring team that works with VA providers to assist with triage and monitoring. This care model has incredible promise, but has been untested in VA. The investigators propose to conduct a randomized trial to evaluate effectiveness of remote temperature monitoring as well as costs. Additionally, the investigators will evaluate the implementation process, including barriers and facilitators to use among key stakeholders.
Detailed description
Objective(s) and Hypotheses: Diabetic foot ulcers (DFU) are common, debilitating, and costly complications of diabetes, disproportionately impacting Black and rural Veterans. Forty percent of individuals have an ulcer recurrence within a year of ulcer healing and 65% within 5 years. Remote temperature monitoring (RTM) of feet is one of the few interventions that reduces the risk of ulcer recurrence. Despite the evidence, adoption has been poor because the original procedures, including the use of handheld thermometers, were burdensome and time-consuming. Podimetrics, a private company, has developed a temperature monitoring system involving a "smart" mat that measure foot temperatures and a remote monitoring team that works with VA providers to assist with triage and monitoring. This care model has incredible promise, but has been untested in VA.
The specific aims of this study are to: 1) Evaluate the effectiveness of RTM vs. usual care in terms of primary (ulceration) and secondary outcomes (severity of ulceration, amputation, hospitalization, emergency room visits, quality of life, satisfaction with care, and self-efficacy for managing diabetes) at 6, 12, 18, and 24 months; 2) Collect data on costs of RTM and compare with usual care costs, if effectiveness is demonstrated; and 3) Evaluate the implementation process, including barriers and facilitators to use among key stakeholders
Research Design: For Aim 1, the investigators will conduct a multi-site randomized controlled study. Aim 2 involves a budget impact analysis to evaluate costs of RTM. Aim 3 involves qualitative interviews to understand barriers and facilitators to implementation of RTM.
Methodology: For Aim 1, the investigators will aim to enroll at least 406 patients who have had a history of DFU or amputation (including active ulcers). Patients will be randomized 1:1 to RTM or usual care (no RTM), with randomization stratified on site and active ulcer vs. not. For Aim 2, the investigators will collect data and observe providers to quantify provider time for selecting patients for RTM, ordering mats, and responding to alerts of "hot spots". The investigators will use medical records to assess patient utilization (ulcer/amputation-related outpatient, inpatient, and emergency room visits) and associated costs of care for patients in the RTM and comparison groups. For Aim 3, the investigators will conduct semi-structured phone interviews with 30-50 Veterans and 12-30 providers and use the Consolidated Framework for Implementation Research to guide data collection and analysis.
Relevance to VA Mission: Findings from this study will be used to inform effective, efficient, and equitable scaling of RTM in VA.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote temperature monitoring + enhanced usual care | Experimental | Other: Remote foot temperature monitoring system, Other: Enhanced usual careEnrollment in remote foot temperature monitoring in addition to enhanced usual care (described below) |
| Enhanced usual care | Other | Other: Enhanced usual careUsual care is based on the VA's amputation prevention program (PAVE - Preventing Amputation in Veterans Everywhere - VHA Directive 1410), which provides a model of care for patients at risk for amputation as well as patients who have already undergone an amputation. Usual care will be enhanced by providing resources (e.g., information through written newsletters) relevant to a population of Veterans with diabetes, including information on nutrition and cooking, physical activities, and Whole Health opportunities |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veteran
- Diabetes diagnosis
- History of foot ulcer (including active ulcer) OR history of lower extremity amputation (including unhealed amputation)
- Able to understand/read English
Key exclusion criteria (6 listed)
- Dementia
- Unable to ambulate
- Bilateral lower extremity amputation
- Ankle brachial index <0.6 or toe brachial index <0.5
- Currently using in-home temperature monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote foot temperature monitoring systemRemote temperature monitoring involves a thermometric mat that can detect "hot spots" on the plantar surface of the foot. The mat has embedded cellular connectivity so that data can be transmitted from the patient's home to the company, where the temperature data can be analyzed. The company has a team of health coaches that work with patients and providers to detect signs of damage early in order to prevent ulceration. | Other | Remote temperature monitoring + enhanced usual care |
| Enhanced usual careUsual care is based on the VA's amputation prevention program (PAVE - Preventing Amputation in Veterans Everywhere - VHA Directive 1410), which provides a model of care for patients at risk for amputation as well as patients who have already undergone an amputation. Usual care will be enhanced by providing resources (e.g., information through written newsletters) relevant to a population of Veterans with diabetes, including information on nutrition and cooking, physical activities, and whole health opportunities | Other | Enhanced usual care, Remote temperature monitoring + enhanced usual care |
Primary outcome
Rate of foot ulceration
Time frame: 24 months
The primary outcome is the presence of new ulceration through 24 months
4 secondary outcomes
Rate of lower limb amputation
Time frame: 24 months
Mean or median quality of life scores
Time frame: 6,12, 18 and 24 months
Mean or median satisfaction with care scores
Time frame: 6,12, 18 and 24 months
Mean or median self-efficacy for diabetes
Time frame: 6, 12, 18, and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No. Subject to IRB approval, de-identified data will be released to a local VAPSHCS and/or national VA research data repository for release to non-VA protocols. The VA research data repository administrator will be responsible for reviewing and responding to requests to release data to non-VA requesters. A data use agreement compliant with VHA Handbooks 1200.12 and 1605.1 will be required between VHA and the requester. Review and approval by VA privacy officer is required prior to disclosure.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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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.
Alyson J. Littman, PhD MPH principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote foot temperature monitoring system in people with Diabetic Foot, run by VA Office of Research and Development at 4 sites 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 6 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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of foot ulceration (time frame: 24 months). 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 22 Jul 2026.