Dermal Thermometry and Self-Care of High Risk Diabetic Patients
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Details and patient eligibility
About
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.
Full description
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
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
vibration perception threshold needs to be greater than 25, palpable pulse, Over 18 years of age Has Diabetes and Neuropathy
Exclusion criteria
No ulcers. Unable to walk without assistance of wheelchair or crutches
Trial design
Primary purpose
Allocation
Interventional model
Masking
400 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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