Effectiveness of Remote Foot Temperature Monitoring

ConditionDiabetic Foot
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorVA Office of Research and Development

About this trial

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

Qualifiers

Veteran

Diabetes diagnosis

History of foot ulcer (including active ulcer) OR history of lower extremity amputation (including unhealed amputation)

Able to understand/read English

Disqualifiers

Dementia

Unable to ambulate

Bilateral lower extremity amputation

Ankle brachial index <0.6 or toe brachial index <0.5

Trial design

Treatments tested in this trial

  • Remote foot temperature monitoring system
  • Enhanced usual care

Treatment groups

800 Participants
are divided into 2 treatment groups