TempTouch IR Thermometry & Diabetic Patient Self-Care
Foot ulcers develop in diabetics with neuropathy because of cumulative injury over the course of several days. These patients do not feel pain, and do not recognize their foot is being injured until a wound develops. Areas about to ulcerate become inflamed and “hot spots” can be identified. This study’s purpose is to evaluate the effectiveness of a home infrared temperature probe designed to forewarn patients that an area on the foot is inflamed so they can take preventive measures. The study will evaluate the incidence of diabetic foot ulcers among high-risk patients, evaluate the cost of home temperature monitoring compared to standard therapy, and evaluate patient satisfaction. 180 diabetics at high-risk of having foot complications will be randomized into 3 treatment arms: 1) standard therapy consisting of regular foot care; 2) standard therapy plus recording of a structured foot evaluation using a hand mirror; and 3) standard therapy plus infrared home temperature assessment to identify “hot spots.” Device patients will measure temperatures at 6 sites on the foot each day. When temperatures are elevated >4°F patients will contact the research nurse and decrease activity. The primary study outcome will be incident foot ulcers and Charcot fractures.
Diabetic Foot Ulcer
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
|Official Title:||Phase 2 Study for Infrared Thermometry Used by Diabetic Patients at Home|
- Intervention of device use decreases foot ulcers.
- Comparison of foot ulceration from enhanced device group as opposed to control group.
|Study Start Date:||June 2000|
|Estimated Study Completion Date:||July 2003|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289497
|United States, Texas|
|Steven R Beito, DPM|
|New Braunfels, Texas, United States, 78130|
|8800 Village Drive, Suite 202|
|San Antonio, Texas, United States, 78217|
|Robert Wunderlich, DPM|
|San Antonio, Texas, United States, 78212|
|Principal Investigator:||Kevin R Higgins, DPM||Xilas Medical, Inc|
|Study Director:||C. Mauli Agrawal, Ph.D.||Xilas Medical, Inc.|