Dermal Thermometry and Self-Care of High Risk Diabetic Patients
Primary Purpose
Diabetes Mellitus, Ulcer, Diabetic Polyneuropathy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
personal dermal thermometer (DT)
Device
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus focused on measuring Activity Cycles, Amputation, Prevention, Temperature
Eligibility 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
Sites / Locations
- Southern Arizona VA Health Care System, Tucson, AZ
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Arm 1
Arm Description
Outcomes
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)
Full Information
NCT ID
NCT00105755
First Posted
March 16, 2005
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00105755
Brief Title
Dermal Thermometry and Self-Care of High Risk Diabetic Patients
Official Title
Dermal Thermometry and Self-Care of High Risk Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Ulcer, Diabetic Polyneuropathy
Keywords
Activity Cycles, Amputation, Prevention, Temperature
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
personal dermal thermometer (DT)
Intervention Type
Device
Intervention Name(s)
Device
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Improve quality of life. Health Related Quality of Life (change over 18 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brent Nixon, DPM MBA BA
Organizational Affiliation
Southern Arizona VA Health Care System, Tucson, AZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Arizona VA Health Care System, Tucson, AZ
City
Tucson
State/Province
Georgia
ZIP/Postal Code
85723
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15277427
Citation
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. doi: 10.2337/diacare.27.8.1980.
Results Reference
result
PubMed Identifier
18060924
Citation
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. doi: 10.1016/j.amjmed.2007.06.028. Erratum In: Am J Med. 2008 Dec;121(12). doi: 10.1016/j.amjmed.2008.09.029.
Results Reference
derived
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Dermal Thermometry and Self-Care of High Risk Diabetic Patients
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