TempTouch IR Thermometry & Diabetic Patient Self-Care
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Purpose
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 |
|---|---|---|
|
Diabetic Polyneuropathy Diabetic Foot Ulcer Diabetes Foot Infection |
Device: TempTouch® |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 180 |
| Study Start Date: | June 2000 |
| Estimated Study Completion Date: | July 2003 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- diagnosis of diabetes by WHO criteria
- ability to provide informed consent
- 18-80 years of age
Exclusion Criteria:
- patients with open ulcers or open amputation sites
- active Charcot arthropathy
- severe peripheral vascular disease
- active foot infection
- dementia -impaired cognitive function-
- history of drug or alcohol abuse within one year of the study
- other conditions based on the PI’s clinical judgment
Contacts and Locations| 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. |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00289497 History of Changes |
| Other Study ID Numbers: | 5R44DK54559 |
| Study First Received: | February 7, 2006 |
| Last Updated: | February 8, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Diabetica Solutions Inc.:
|
Charcot foot ulceration neuropathy |
Additional relevant MeSH terms:
|
Ulcer Foot Ulcer Polyneuropathies Diabetic Foot Diabetic Neuropathies Focal Infection Pathologic Processes Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer |
Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Infection |
ClinicalTrials.gov processed this record on May 23, 2013