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: l) 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 about 4 degrees F patients will contact the research nurse and decrease activity. The primary study outcome will be incident foot ulcers and Charcot fractures.

Proposed Commercial Applications

The FootScan dermal thermometry device promises to revolutionize patient self-care via a simple daily procedure of assessing one's foot temperatures in the home. This simple means will serve to decrease neuropathic ulcers, amputations and diabetic morbidity. In effect, the FootScan, should become the missing """"""""early warning sign"""""""" for patients with sensory loss.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44DK054559-03
Application #
6381252
Study Section
Special Emphasis Panel (ZRG1-SSS-5 (06))
Program Officer
Quatrano, Louis A
Project Start
1998-09-30
Project End
2002-07-31
Budget Start
2001-08-01
Budget End
2002-07-31
Support Year
3
Fiscal Year
2001
Total Cost
$335,572
Indirect Cost
Name
Diabetica Solutions, Inc.
Department
Type
DUNS #
115243805
City
San Antonio
State
TX
Country
United States
Zip Code
78249
Lavery, Lawrence A; Higgins, Kevin R; Lanctot, Dan R et al. (2007) Preventing diabetic foot ulcer recurrence in high-risk patients: use of temperature monitoring as a self-assessment tool. Diabetes Care 30:14-20