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Effectiveness of Remote Foot Temperature Monitoring
NCT05728411 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- OTHER Remote foot temperature monitoring system
- OTHER Enhanced usual care
Study Locations (4)
Washington
- VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle
- Spokane VA Medical Center, Spokane, WA — Spokane
Illinois
- Edward Hines Jr. VA Hospital, Hines, IL — Hines
Virginia
- Richmond VA Medical Center, Richmond, VA — Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2023-10-02 |
| Est. Completion | 2031-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05728411
The ClinicalTrials.gov registry entry for NCT05728411 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Diabetic Foot appearing as the primary indexed condition, and to 2 interventions — of which Remote foot temperature monitoring system is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05728411 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Washington, Illinois, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05728411 about?
NCT05728411 is a clinical study titled "Effectiveness of Remote Foot Temperature Monitoring". 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 ...
What is the current status of trial NCT05728411?
This trial is currently recruiting. It is a NA study. The enrollment target is 800 participants. The study started on 2023-10-02. Estimated completion is 2031-12-31.
What conditions does trial NCT05728411 study?
This clinical trial studies the following conditions: Diabetic Foot. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05728411?
The interventions under investigation include: Remote foot temperature monitoring system (OTHER), Enhanced usual care (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05728411?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05728411 being conducted?
This trial has 4 study locations across Illinois, Virginia, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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