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NCT05728411 · ClinicalTrials.gov registry record · NA
Effectiveness of Remote Foot Temperature Monitoring
A NA study of Diabetic Foot, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 800
- Enrollment target
- 4
- Study locations
NCT05728411 is a NA study of Diabetic Foot that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 800 participants, below the 10,315-participant average among 30 other Diabetic Foot trials with a reported enrollment target (92% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT05728411, a NA study of Diabetic Foot, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 800 participants
- Enrollment target
- 4
- Study locations
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, categorized as NA. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 10,315-participant average among 30 other Diabetic Foot trials with a reported enrollment target (92% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
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.
NCT05728411 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Washington, Illinois, Virginia.
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.
What interventions are being tested in trial NCT05728411?
The interventions under investigation include: Remote foot temperature monitoring system (OTHER), Enhanced usual care (OTHER).
Who is sponsoring clinical trial NCT05728411?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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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Related
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