Effectiveness of Remote Foot Temperature Monitoring

Running, not enrolling · Not applicable

Conditions studied: Diabetic Foot

In brief

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.

Key facts

Study ID

NCT05728411

Run by

VA Office of Research and Development

People needed

379

Starts

2023-10-02

Expected to finish

2031-12-31

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States
• Richmond VA Medical Center, Richmond, VA — Richmond, Virginia, United States
• VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States
• Spokane VA Medical Center, Spokane, WA — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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