NCT05728411 Effectiveness of Remote Foot Temperature Monitoring
| NCT ID | NCT05728411 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Diabetic Foot |
| Study Type | INTERVENTIONAL |
| Enrollment | 800 participants |
| Start Date | 2023-10-02 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 800 participants in total. It began in 2023-10-02 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Veteran * Diabetes diagnosis * History of foot ulcer (including active ulcer) OR history of lower extremity amputation (including unhealed amputation) * Able to understand/read English Exclusion Criteria: * 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 & Investigator
Alyson J. Littman, PhD MPH
PRINCIPAL INVESTIGATOR
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Frequently Asked Questions
Who can join the NCT05728411 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Diabetic Foot. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05728411 currently recruiting?
Yes, NCT05728411 is actively recruiting participants. Contact the research team at Rachel.Thomas3@va.gov for enrollment information.
Where is the NCT05728411 trial being conducted?
This trial is being conducted at Hines, United States, Richmond, United States, Seattle, United States, Spokane, United States.
Who is sponsoring the NCT05728411 clinical trial?
NCT05728411 is sponsored by VA Office of Research and Development. The principal investigator is Alyson J. Littman, PhD MPH at VA Puget Sound Health Care System Seattle Division, Seattle, WA. The trial plans to enroll 800 participants.