Actively Recruiting

Phase Not Applicable
Age: 18Years - 89Years
All Genders
NCT05728411

Effectiveness of Remote Foot Temperature Monitoring

Led by VA Office of Research and Development · Updated on 2025-09-11

800

Participants Needed

4

Research Sites

430 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effectiveness of Remote Foot Temperature Monitoring

Who Can Participate

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Veteran
  • Diagnosed with diabetes
  • History of foot ulcer (including active ulcer) or lower extremity amputation (including unhealed amputation)
  • Able to understand and read English
Not Eligible

You will not qualify if you...

  • Dementia
  • Unable to walk
  • Bilateral lower extremity amputation
  • Ankle brachial index less than 0.6 or toe brachial index less than 0.5
  • Currently using in-home temperature monitoring
  • Prisoner

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States, 60141-3030

Actively Recruiting

2

Richmond VA Medical Center, Richmond, VA

Richmond, Virginia, United States, 23249-0001

Actively Recruiting

3

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, United States, 98108-1532

Actively Recruiting

4

Spokane VA Medical Center, Spokane, WA

Spokane, Washington, United States, 99205-6185

Actively Recruiting

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Research Team

R

Rachel M Thomas

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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