Dermal Thermometry and Self-Care of High Risk Diabetic Patients

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ClinicalTrials.gov Identifier: NCT00105755

Recruitment Status : Completed

First Posted : March 17, 2005

Last Update Posted : April 7, 2015

Sponsor:

Information provided by (Responsible Party):

VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description

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:

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

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

Outcome Measures

Primary Outcome Measures :

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 :

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105755

Locations

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

Sponsors and Collaborators

US Department of Veterans Affairs

Investigators

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

More Information

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.

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Responsible Party:	US Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00105755
Other Study ID Numbers:	IIR 20-059
First Posted:	March 17, 2005 Key Record Dates
Last Update Posted:	April 7, 2015
Last Verified:	April 2015

Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):


Activity Cycles Amputation Prevention Temperature

Additional relevant MeSH terms:

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Polyneuropathies Diabetic Neuropathies Peripheral Nervous System Diseases Neuromuscular Diseases	Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases

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