Dermal Thermometry and Self-Care of High Risk Diabetic Patients

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus; Ulcer; Diabetic Polyneuropathy	Device: personal dermal thermometer (DT); Device: Device	Not Applicable

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	400 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Dermal Thermometry and Self-Care of High Risk Diabetic Patients
Study Start Date :	January 2003
Actual Study Completion Date :	February 2006

Arms and Interventions

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Arm	Intervention/treatment
Arm 1	Device: personal dermal thermometer (DT); Device: Device

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. Improve quality of life. Health Related Quality of Life (change over 18 months)

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

United States, Georgia
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Georgia, United States, 85723

Sponsors and Collaborators

VA Office of Research and Development

Investigators

Principal Investigator:	Brent Nixon, DPM MBA BA	Southern Arizona VA Health Care System, Tucson, AZ

More Information

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Publications of Results:

Armstrong DG, Lavery LA, Holtz-Neiderer K, Mohler MJ, Wendel CS, Nixon BP, Boulton AJ. Variability in activity may precede diabetic foot ulceration. Diabetes Care. 2004 Aug;27(8):1980-4.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Armstrong DG, Holtz-Neiderer K, Wendel C, Mohler MJ, Kimbriel HR, Lavery LA. Skin temperature monitoring reduces the risk for diabetic foot ulceration in high-risk patients. Am J Med. 2007 Dec;120(12):1042-6. Erratum in: Am J Med. 2008 Dec;121(12). doi: 10.1016/j.amjmed.2008.09.029.

Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT00105755 History of Changes
Other Study ID Numbers:	IIR 20-059
First Posted:	March 17, 2005
Last Update Posted:	April 7, 2015
Last Verified:	April 2015

Keywords provided by VA Office of Research and Development:

Activity Cycles; Amputation; Prevention; Temperature

Additional relevant MeSH terms:

Diabetes Mellitus; Polyneuropathies; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases	Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications