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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00289497
Other study ID # 5R44DK054559
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received February 7, 2006
Last updated February 8, 2006
Start date June 2000
Est. completion date July 2003

Study information

Verified date February 2006
Source Diabetica Solutions Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention


Intervention

Device:
TempTouch®


Locations

Country Name City State
United States Steven R Beito, DPM New Braunfels Texas
United States 8800 Village Drive, Suite 202 San Antonio Texas
United States Robert Wunderlich, DPM San Antonio Texas

Sponsors (2)

Lead Sponsor Collaborator
Diabetica Solutions Inc. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lavery LA, Higgins KR, Lanctot DR, Constantinides GP, Zamorano RG, Armstrong DG, Athanasiou KA, Agrawal CM. Home monitoring of foot skin temperatures to prevent ulceration. Diabetes Care. 2004 Nov;27(11):2642-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Intervention of device use decreases foot ulcers.
Secondary Comparison of foot ulceration from enhanced device group as opposed to control group.
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