Dermal Thermometry and Self-Care of High Risk Diabetic Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Dermal Thermometry and Self-Care of High Risk Diabetic Patients

Conditions
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Diabetes Mellitus, Ulcer, Diabetic Polyneuropathy

Intervention / Treatment
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* Device: personal dermal thermometer (DT)
* Device: Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br> | Device: personal dermal thermometer (DT)<br> <br> Device: Device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduce the risk for lower extremity ulceration and amputation in veterans at high risk for these complications.; Incidence of diabetic foot ulcers over 18 months. Incidence of foot infections over 18 months. Incidence of Charcot fractures. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve quality of life. Health Related Quality of Life (change over 18 months) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Activity Cycles, Amputation, Prevention, Temperature