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

Not Applicable

Completed

• Conditions: Foot Ulcer, Diabetic
• Interventions: Device: Daily use of podimetrics smart-foot mat

• 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

Arm && Interventions

Group	Intervention	Description
Participant cohort	Daily use of podimetrics smart-foot mat	Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.

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

Limb Preservation Platform; 🇺🇸 Fresno, California, United States

Miami VA Healthcare System; 🇺🇸 Miami, Florida, United States

MetroWest Medical Center; 🇺🇸 Framingham, Massachusetts, United States

VA Long Beach Health System; 🇺🇸 Long Beach, California, United States

Center for Clinical Research Castro Valley; 🇺🇸 Castro Valley, California, United States

University of Arizona; 🇺🇸 Tucson, Arizona, United States

Greenville Health System; 🇺🇸 Greenville, South Carolina, United States