TempTouch IR Thermometry & Diabetic Patient Self-Care

Completed · Phase 2/Phase 3

Conditions studied: Diabetic Polyneuropathy, Diabetic Foot Ulcer, Diabetes, Foot Infection

In brief

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.

Key facts

Study ID

NCT00289497

Run by

Diabetica Solutions Inc.

People needed

180

Starts

2000-06-01

Expected to finish

2003-07-01

Last updated by the study team

2006-02-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• diagnosis of diabetes by WHO criteria
• ability to provide informed consent
• 18-80 years of age

You may not qualify if…

• 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

Where it is running

• Steven R Beito, DPM — New Braunfels, Texas, United States
• Robert Wunderlich, DPM — San Antonio, Texas, United States
• 8800 Village Drive, Suite 202 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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