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Dermal Thermometry and Self-Care of High Risk Diabetic Patients
This study has been completed.
First Received: March 16, 2005   Last Updated: April 23, 2008   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00105755
  Purpose

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 Intervention
Diabetes Mellitus
Ulcer
Diabetic Polyneuropathy
Device: personal dermal thermometer (DT)

MedlinePlus related topics: Diabetes Diabetic Foot Foot Health
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: Dermal Thermometry and Self-Care of High Risk Diabetic Patients

Further study details as provided by Department of Veterans Affairs:

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. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improve quality of life. Health Related Quality of Life (change over 18 months) [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: January 2003
Study Completion Date: February 2006
Arms Assigned Interventions
1 Device: personal dermal thermometer (DT)

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00105755

Locations
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
Investigators
Principal Investigator: Brent Nixon, DPM MBA BA Atlanta VA Medical and Rehab Center, Decatur
  More Information

Publications:
Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: Department of Veterans Affairs ( Nixon, Brent - Principal Investigator )
Study ID Numbers: IIR 20-059
Study First Received: March 16, 2005
Last Updated: April 23, 2008
ClinicalTrials.gov Identifier: NCT00105755     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Activity Cycles
Amputation
Prevention
Temperature

Study placed in the following topic categories:
Metabolic Diseases
Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Ulcer
Diabetes Mellitus
Polyneuropathies
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Diabetes Complications

Additional relevant MeSH terms:
Metabolic Diseases
Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Nervous System Diseases
Polyneuropathies
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Diabetes Complications

ClinicalTrials.gov processed this record on May 07, 2009