Effectiveness of Remote Foot Temperature Monitoring (STOP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot
• Intervention / Treatment: Other: Remote foot temperature monitoring system; Other: Enhanced usual care

Detailed Description

Objective(s) and Hypotheses: Diabetic foot ulcers (DFU) 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. Remote temperature monitoring (RTM) of feet 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 measure foot temperatures 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 specific aims of this study are to: 1) Evaluate the effectiveness of RTM vs. usual care in terms of primary (ulceration) and secondary outcomes (severity of ulceration, amputation, hospitalization, emergency room visits, quality of life, satisfaction with care, and self-efficacy for managing diabetes) at 6, 12, 18, and 24 months; 2) Collect data on costs of RTM and compare with usual care costs, if effectiveness is demonstrated; and 3) Evaluate the implementation process, including barriers and facilitators to use among key stakeholders

Research Design: For Aim 1, the investigators will conduct a multi-site randomized controlled study. Aim 2 involves a budget impact analysis to evaluate costs of RTM. Aim 3 involves qualitative interviews to understand barriers and facilitators to implementation of RTM.

Methodology: For Aim 1, the investigators will aim to enroll at least 406 patients who have had a history of DFU or amputation (including active ulcers). Patients will be randomized 1:1 to RTM or usual care (no RTM), with randomization stratified on site and active ulcer vs. not. For Aim 2, the investigators will collect data and observe providers to quantify provider time for selecting patients for RTM, ordering mats, and responding to alerts of "hot spots". The investigators will use medical records to assess patient utilization (ulcer/amputation-related outpatient, inpatient, and emergency room visits) and associated costs of care for patients in the RTM and comparison groups. For Aim 3, the investigators will conduct semi-structured phone interviews with 30-50 Veterans and 12-30 providers and use the Consolidated Framework for Implementation Research to guide data collection and analysis.

Relevance to VA Mission: Findings from this study will be used to inform effective, efficient, and equitable scaling of RTM in VA.

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel M Thomas; Phone Number: (206) 277-4161; Email: Rachel.Thomas3@va.gov

Study Locations

• United States
  • Illinois
    • Hines, Illinois, United States, 60141-3030
      • Recruiting
      • Edward Hines Jr. VA Hospital, Hines, IL
      • Contact: Rodney M Stuck, DPM; Phone Number: 21700 708-202-8387; Email: Rodney.Stuck@va.gov
      • Sub-Investigator: Rodney M Stuck, DPM
  • Virginia
    • Richmond, Virginia, United States, 23249-0001
      • Recruiting
      • Richmond VA Medical Center, Richmond, VA
      • Contact: Jonathan N Brantley; Phone Number: 2554 804-675-5000; Email: Jonathan.Brantley@va.gov
      • Sub-Investigator: Jonathan N Brantley
  • Washington
    • Seattle, Washington, United States, 98108-1532
      • Recruiting
      • VA Puget Sound Health Care System Seattle Division, Seattle, WA
      • Contact: Rachel M Thomas; Phone Number: 206-277-4161; Email: Rachel.Thomas3@va.gov
      • Principal Investigator: Alyson J. Littman, PhD MPH
    • Spokane, Washington, United States, 99205-6185
      • Recruiting
      • Spokane VA Medical Center, Spokane, WA
      • Contact: Marc Jones, DPM; Phone Number: 509-434-6004; Email: marc.jones@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote temperature monitoring + enhanced usual care; Enrollment in remote foot temperature monitoring in addition to enhanced usual care (described below)	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
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of foot ulceration	The primary outcome is the presence of new ulceration through 24 months	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of lower limb amputation	Any level of lower extremity amputation	24 months
Mean or median quality of life scores	Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health v1.2. The global scale produces two scores: Global Mental Health and Global Physical Health. Raw scores are converted to T-score values (higher values indicate better health). Minimum and maximum T scores for Global Mental Health are 21.2 and 67.6, respectively. Minimum and maximum T scores for Global Physical Health are 16.2 and 67.7, respectively.	6,12, 18 and 24 months
Mean or median satisfaction with care scores	Short assessment of patient satisfaction (SAPS) by Hawthorne G et al (2006) which includes 7 items. Each item is scored on a 0 to 4 scale. The score range is from 0 (extremely dissatisfied) to 28 (extremely satisfied).	6,12, 18 and 24 months
Mean or median self-efficacy for diabetes	8-item Self-efficacy for diabetes measure that has a range of 1 to 10. Higher scores indicate higher self-efficacy.	6, 12, 18, and 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utilization (outpatient visits, emergency room visits, hospitalizations) - any vs. none and number	Based on electronic medical record data	6, 12, 18, and 24 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Alyson J. Littman, PhD MPH, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: diabetic foot; Dept. of Veterans Affairs; remote sensing technology
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Skin and Connective Tissue Diseases; Diabetic Foot
• Other Study ID Numbers: IIR 21-176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Subject to IRB approval, de-identified data will be released to a local VAPSHCS and/or national VA research data repository for release to non-VA protocols. The VA research data repository administrator will be responsible for reviewing and responding to requests to release data to non-VA requesters. A data use agreement compliant with VHA Handbooks 1200.12 and 1605.1 will be required between VHA and the requester. Review and approval by VA privacy officer is required prior to disclosure.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No