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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00105755 |
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) |
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 |
Estimated Enrollment: | 400 |
Study Start Date: | January 2003 |
Study Completion Date: | February 2006 |
Arms | Assigned Interventions |
---|---|
1 | Device: personal dermal thermometer (DT) |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
United States, Georgia | |
Atlanta VA Medical and Rehab Center, Decatur | |
Decatur, Georgia, United States, 30033 |
Principal Investigator: | Brent Nixon, DPM MBA BA | Atlanta VA Medical and Rehab Center, Decatur |
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 |
Activity Cycles Amputation Prevention Temperature |
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 |
Nervous System Diseases |