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
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Ulcer Diabetic Polyneuropathy||Device: personal dermal thermometer (DT) Device: Device||Not Applicable|
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.
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.
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.
Project work is complete
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dermal Thermometry and Self-Care of High Risk Diabetic Patients|
|Study Start Date :||January 2003|
|Actual Study Completion Date :||February 2006|
|Arm 1||Device: personal dermal thermometer (DT) Device: Device|
- 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.
- Improve quality of life. Health Related Quality of Life (change over 18 months)
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
|United States, Georgia|
|Southern Arizona VA Health Care System, Tucson, AZ|
|Tucson, Georgia, United States, 85723|
|Principal Investigator:||Brent Nixon, DPM MBA BA||Southern Arizona VA Health Care System, Tucson, AZ|