In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers



Status:Completed
Conditions:Gastrointestinal, Podiatry, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2013

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The purpose of this study is to investigate the accuracy of a Smart Foot Mat for signals
associated with diabetic foot ulcers in high-risk patients.


Inclusion Criteria:

- Male/Female, 18 years or older

- Diagnosis of type 1 or type 2 Diabetes Mellitus, controlled or uncontrolled

- Ankle Brachial Index (ABI) >0.5

- Patient with history of previous foot ulcer.

Exclusion Criteria:

- Active Charcot foot disease

- One or more plantar foot ulcers (UT Grade 1A-C, 2A-C & 3A-C)

- Active Infection/Gangrene

- Active malignancy

- Immunosuppressive disease

- History of alcohol or drug abuse

- Pregnant women (verbal confirmation or confirmation obtained within current medical
records)

- Cognitive deficit

- 2+ or great lower extremity edema

- End stage renal disease

- History of major lower extremity amputation (below knee or above knee amputation)

- Other issue that, at the discretion of the investigator, renders the subject
ineligible for participation.
We found this trial at
8
sites
Phoenix, Arizona 85012
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Phoenix, AZ
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Castro Valley, California 94546
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Castro Valley, CA
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Framingham, Massachusetts 01702
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Framingham, MA
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Fresno, California 93721
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Fresno, CA
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Greenville, South Carolina 29615
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Greenville, SC
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Long Beach, California 90822
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Long Beach, CA
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Miami, Florida 33136
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Miami, FL
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Tuscon, Arizona 85719
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Tuscon, AZ
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