Effectiveness of Remote Foot Temperature Monitoring
STOP
Home Foot-temperature Monitoring Through Smart Mat Technology to Improve Access, Equity, and Outcomes in High-risk Patients With Diabetes
1 other identifier
interventional
800
1 country
4
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2023
CompletedFirst Posted
Study publicly available on registry
February 15, 2023
CompletedStudy Start
First participant enrolled
October 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2031
September 11, 2025
September 1, 2025
3.2 years
February 3, 2023
September 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of foot ulceration
The primary outcome is the presence of new ulceration through 24 months
24 months
Secondary Outcomes (4)
Rate of lower limb amputation
24 months
Mean or median quality of life scores
6,12, 18 and 24 months
Mean or median satisfaction with care scores
6,12, 18 and 24 months
Mean or median self-efficacy for diabetes
6, 12, 18, and 24 months
Other Outcomes (1)
Utilization (outpatient visits, emergency room visits, hospitalizations) - any vs. none and number
6, 12, 18, and 24 months
Study Arms (2)
Remote temperature monitoring + enhanced usual care
EXPERIMENTALEnrollment in remote foot temperature monitoring in addition to enhanced usual care (described below)
Enhanced usual care
OTHERUsual 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
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- Veteran
- Diabetes diagnosis
- History of foot ulcer (including active ulcer) OR history of lower extremity amputation (including unhealed amputation)
- Able to understand/read English
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030, United States
Richmond VA Medical Center, Richmond, VA
Richmond, Virginia, 23249-0001, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532, United States
Spokane VA Medical Center, Spokane, WA
Spokane, Washington, 99205-6185, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alyson J. Littman, PhD MPH
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2023
First Posted
February 15, 2023
Study Start
October 2, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2031
Last Updated
September 11, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
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.