Diabetes Mellitus Clinical Trial
Official title:
Dermal Thermometry and Self-Care of High Risk Diabetic Patients
Foot ulcers remain the most common reason for hospital admission among veterans with diabetes. Healing and preventing these wounds should be a high priority for clinicians treating these high-risk patients. Previous work by the investigators has suggested that diabetic foot ulcers are preceded by inflammation, which can potentially be detected with a thermometer.
Background:
Foot ulcers remain the most common reason for hospital admission among veterans with
diabetes. Healing and preventing these wounds should be a high priority for clinicians
treating these high-risk patients. Previous work by the investigators has suggested that
diabetic foot ulcers are preceded by inflammation, which can potentially be detected with a
thermometer.
Objectives:
The purpose of this project is to evaluate the utility of a novel personal dermal
thermometry system to empower patients and caregivers and thereby reduce the risk for lower
extremity ulceration and amputation in veterans at high risk for these complications.
Methods:
In this randomized clinical trial, 384 patients are being enrolled and assigned to either
standard of care (SC) or SC plus a personal dermal thermometer (DT) to evaluate and log
their plantar skin temperatures. All patients are given access to a 24 hour "hot foot line"
to call for immediate access to care if they identify a hot spot (DT group) or a site of
concern on standard self-evaluation (SC). All patients are assigned a sophisticated
computerized activity monitor, which allows investigators access to time and magnitude of
activity, downloaded at regular patient visits.
Status:
Project work is complete
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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