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TempTouch IR Thermometry & Diabetic Patient Self-Care
This study has been completed.
Sponsors and Collaborators: Diabetica Solutions Inc.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: Diabetica Solutions Inc.
ClinicalTrials.gov Identifier: NCT00289497
  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 II
Phase III

MedlinePlus related topics: Diabetes Diabetic Foot Foot Health
U.S. FDA Resources
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

Further study details as provided by Diabetica Solutions Inc.:

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

Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289497

Locations
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
Sponsors and Collaborators
Diabetica Solutions Inc.
Investigators
Principal Investigator: Kevin R Higgins, DPM Xilas Medical, Inc
Study Director: C. Mauli Agrawal, Ph.D. Xilas Medical, Inc.
  More Information

Xilas Medical home page discussing TempTouch device  This link exits the ClinicalTrials.gov site

Publications of Results:
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

Keywords provided by Diabetica Solutions Inc.:
Charcot
foot
ulceration
neuropathy

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases
Infection

ClinicalTrials.gov processed this record on January 16, 2009