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

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

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.