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Active Not Recruiting
NCT05728411
Effectiveness of Remote Foot Temperature Monitoring
Conditions: Diabetic Foot
Sex: All
Ages: 18 Years – 89 Years
Healthy volunteers: No
Phase: NA
Enrollment: 379
Sponsor: VA Office of Research and Development
Location: Edward Hines Jr. VA Hospital, Hines, IL Hines Illinois
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT05728411). StuddyBuddy aggregates publicly available trial information.