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

Not Applicable

Completed

• Conditions: Foot Ulcer, Diabetic

• Registration Number: NCT02647346
• Lead Sponsor: Podimetrics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-06
• Results First Submitted: 2020-01-14
• Results First Submitted QC: 2020-01-24
• Status Verified: 2020-02
• Results First Posted: 2020-02-05
• Last Update Submitted: 2020-02-08
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Occurrence of Plantar Diabetic Foot Ulcer	Through study completion or subject withdrawal (34 weeks per-protocol)

Secondary Outcome Measures

Name	Time	Method
Device-related Trips/Falls	Through study completion or subject withdrawal (34 weeks per-protocol)
Subject Adherence in Daily Use of the Study Device	Through study completion or subject withdrawal (34 weeks per-protocol)
Device-related Injuries	Through study completion or subject withdrawal (34 weeks per-protocol)

Trial Locations

Locations (8)

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