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Effectiveness of Remote Foot Temperature Monitoring

NCT05728411 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2025-09-11

No results posted yet for this study

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.

Conditions

  • Diabetic Foot

Interventions

OTHER

Remote 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.

OTHER

Enhanced 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

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Alyson J. Littman, PhD MPH · VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-02
Primary Completion
2026-12-31
Completion
2031-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05728411 on ClinicalTrials.gov