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

Completed · Not applicable

Conditions studied: Foot Ulcer, Diabetic

In brief

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.

Key facts

Study ID

NCT02647346

Run by

Podimetrics, Inc.

People needed

132

Starts

2013-11-01

Expected to finish

2015-02-01

Last updated by the study team

2020-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Phoenix VA Health Care System — Phoenix, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• Center for Clinical Research Castro Valley — Castro Valley, California, United States
• Limb Preservation Platform — Fresno, California, United States
• VA Long Beach Health System — Long Beach, California, United States
• Miami VA Healthcare System — Miami, Florida, United States
• MetroWest Medical Center — Framingham, Massachusetts, United States
• Greenville Health System — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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