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Sponsors and Collaborators: |
Diabetica Solutions Inc. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | Diabetica Solutions Inc. |
ClinicalTrials.gov Identifier: | NCT00289497 |
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.
Condition | Intervention | Phase |
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Diabetic Polyneuropathy Diabetic Foot Ulcer Diabetes Foot Infection |
Device: TempTouch® |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Phase 2 Study for Infrared Thermometry Used by Diabetic Patients at Home |
Estimated Enrollment: | 180 |
Study Start Date: | June 2000 |
Estimated Study Completion Date: | July 2003 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
8800 Village Drive, Suite 202 | |
San Antonio, Texas, United States, 78217 | |
Steven R Beito, DPM | |
New Braunfels, Texas, United States, 78130 | |
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. |
Study ID Numbers: | 5R44DK54559 |
Study First Received: | February 7, 2006 |
Last Updated: | February 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00289497 |
Health Authority: | United States: Food and Drug Administration |
Charcot foot ulceration neuropathy |
Foot Ulcer Diabetic Neuropathies Skin Diseases Ulcer Vascular Diseases Polyneuropathies Diabetes Mellitus Endocrine System Diseases Foot Diseases |
Diabetic Angiopathies Neuromuscular Diseases Peripheral Nervous System Diseases Endocrinopathy Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |
Nervous System Diseases Cardiovascular Diseases Infection |