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

Primary Purpose

Foot Ulcer, Diabetic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily use of podimetrics smart-foot mat
Sponsored by
Podimetrics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Foot Ulcer, Diabetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Phoenix VA Health Care System
  • University of Arizona
  • Center for Clinical Research Castro Valley
  • Limb Preservation Platform
  • VA Long Beach Health System
  • Miami VA Healthcare System
  • MetroWest Medical Center
  • Greenville Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participant cohort

Arm Description

Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.

Outcomes

Primary Outcome Measures

Occurrence of Plantar Diabetic Foot Ulcer

Secondary Outcome Measures

Subject Adherence in Daily Use of the Study Device
Device-related Trips/Falls
Device-related Injuries

Full Information

First Posted
January 4, 2016
Last Updated
February 8, 2020
Sponsor
Podimetrics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02647346
Brief Title
In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers
Official Title
In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Podimetrics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Ulcer, Diabetic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participant cohort
Arm Type
Experimental
Arm Description
Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
Intervention Type
Device
Intervention Name(s)
Daily use of podimetrics smart-foot mat
Primary Outcome Measure Information:
Title
Occurrence of Plantar Diabetic Foot Ulcer
Time Frame
Through study completion or subject withdrawal (34 weeks per-protocol)
Secondary Outcome Measure Information:
Title
Subject Adherence in Daily Use of the Study Device
Time Frame
Through study completion or subject withdrawal (34 weeks per-protocol)
Title
Device-related Trips/Falls
Time Frame
Through study completion or subject withdrawal (34 weeks per-protocol)
Title
Device-related Injuries
Time Frame
Through study completion or subject withdrawal (34 weeks per-protocol)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Phoenix VA Health Care System
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Center for Clinical Research Castro Valley
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Limb Preservation Platform
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Facility Name
VA Long Beach Health System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Miami VA Healthcare System
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
MetroWest Medical Center
City
Framingham
State/Province
Massachusetts
ZIP/Postal Code
01702
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31956341
Citation
Petersen BJ, Rothenberg GM, Lakhani PJ, Zhou M, Linders DR, Bloom JD, Wood KA, Armstrong DG. Ulcer metastasis? Anatomical locations of recurrence for patients in diabetic foot remission. J Foot Ankle Res. 2020 Jan 13;13:1. doi: 10.1186/s13047-020-0369-3. eCollection 2020.
Results Reference
derived
PubMed Identifier
28465454
Citation
Frykberg RG, Gordon IL, Reyzelman AM, Cazzell SM, Fitzgerald RH, Rothenberg GM, Bloom JD, Petersen BJ, Linders DR, Nouvong A, Najafi B. Feasibility and Efficacy of a Smart Mat Technology to Predict Development of Diabetic Plantar Ulcers. Diabetes Care. 2017 Jul;40(7):973-980. doi: 10.2337/dc16-2294. Epub 2017 May 2.
Results Reference
derived

Learn more about this trial

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

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