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 |
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.
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
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