Dermal Thermometry and Self-Care of High Risk Diabetic Patients

Not Applicable

Completed

• Conditions: Diabetic Polyneuropathy; Diabetes Mellitus; Ulcer
• Interventions: Device: personal dermal thermometer (DT); Device: Device

• Registration Number: NCT00105755
• Lead Sponsor: US Department of Veterans Affairs

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2005-03-16
• Study First Submitted QC: 2005-03-16
• Study First Posted: 2005-03-17
• Study Completion: 2006-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

vibration perception threshold needs to be greater than 25, palpable pulse, Over 18 years of age Has Diabetes and Neuropathy

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Exclusion Criteria

No ulcers. Unable to walk without assistance of wheelchair or crutches

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	personal dermal thermometer (DT)	-
Arm 1	Device	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Improve quality of life. Health Related Quality of Life (change over 18 months)

Trial Locations

Locations (1)

Southern Arizona VA Health Care System, Tucson, AZ; 🇺🇸 Tucson, Georgia, United States