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TempTouch IR Thermometry & Diabetic Patient Self-Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00289497
Recruitment Status : Completed
First Posted : February 9, 2006
Last Update Posted : February 9, 2006
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Diabetica Solutions Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Polyneuropathy Diabetic Foot Ulcer Diabetes Foot Infection Device: TempTouch® Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Phase 2 Study for Infrared Thermometry Used by Diabetic Patients at Home
Study Start Date : June 2000
Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Primary Outcome Measures :
  1. Intervention of device use decreases foot ulcers.

Secondary Outcome Measures :
  1. Comparison of foot ulceration from enhanced device group as opposed to control group.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00289497

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United States, Texas
Steven R Beito, DPM
New Braunfels, Texas, United States, 78130
Robert Wunderlich, DPM
San Antonio, Texas, United States, 78212
8800 Village Drive, Suite 202
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Diabetica Solutions Inc.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Kevin R Higgins, DPM Xilas Medical, Inc
Study Director: C. Mauli Agrawal, Ph.D. Xilas Medical, Inc.
Publications of Results:
Layout table for additonal information Identifier: NCT00289497    
Other Study ID Numbers: 5R44DK054559 ( U.S. NIH Grant/Contract )
First Posted: February 9, 2006    Key Record Dates
Last Update Posted: February 9, 2006
Last Verified: February 2006
Keywords provided by Diabetica Solutions Inc.:
Additional relevant MeSH terms:
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Diabetic Neuropathies
Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Foot Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases