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

February 8, 2020 updated by: Podimetrics, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Phoenix VA Health Care System
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • Castro Valley, California, United States, 94546
        • Center for Clinical Research Castro Valley
      • Fresno, California, United States, 93721
        • Limb Preservation Platform
      • Long Beach, California, United States, 90822
        • VA Long Beach Health System
    • Florida
      • Miami, Florida, United States, 33125
        • Miami VA Healthcare System
    • Massachusetts
      • Framingham, Massachusetts, United States, 01702
        • MetroWest Medical Center
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Greenville Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of Plantar Diabetic Foot Ulcer
Time Frame: Through study completion or subject withdrawal (34 weeks per-protocol)
Through study completion or subject withdrawal (34 weeks per-protocol)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Podimetrics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

January 4, 2016

First Submitted That Met QC Criteria

January 4, 2016

First Posted (Estimate)

January 6, 2016

Study Record Updates

Last Update Posted (Actual)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 8, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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