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Dermal Thermometry and Self-Care of High Risk Diabetic Patients
This study has been completed.
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 of Results:
Publications indexed to this study:
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  
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
Metabolic disorder
Glucose Metabolism Disorders
Diabetes Complications

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009