TempTouch IR Thermometry & Diabetic Patient Self-Care

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Diabetica Solutions Inc.
ClinicalTrials.gov Identifier:
NCT00289497
First received: February 7, 2006
Last updated: February 8, 2006
Last verified: February 2006
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
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

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 August 21, 2014