RecruitingNot ApplicableNCT05728411

Effectiveness of Remote Foot Temperature Monitoring

Home Foot-temperature Monitoring Through Smart Mat Technology to Improve Access, Equity, and Outcomes in High-risk Patients With Diabetes


Sponsor

VA Office of Research and Development

Enrollment

800 participants

Start Date

Oct 2, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 89 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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

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Interventions

OTHERRemote foot temperature monitoring system

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.

OTHEREnhanced usual care

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


Locations(4)

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

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NCT05728411


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