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

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ClinicalTrials.gov Identifier: NCT02647346
Recruitment Status : Completed
First Posted : January 6, 2016
Results First Posted : February 5, 2020
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Podimetrics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Foot Ulcer, Diabetic Device: Daily use of podimetrics smart-foot mat Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers
Study Start Date : November 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of Plantar Diabetic Foot Ulcer [ Time Frame: Through study completion or subject withdrawal (34 weeks per-protocol) ]

Secondary Outcome Measures :
  1. Subject Adherence in Daily Use of the Study Device [ Time Frame: Through study completion or subject withdrawal (34 weeks per-protocol) ]
  2. Device-related Trips/Falls [ Time Frame: Through study completion or subject withdrawal (34 weeks per-protocol) ]
  3. Device-related Injuries [ Time Frame: Through study completion or subject withdrawal (34 weeks per-protocol) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647346


Locations
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United States, Arizona
Phoenix VA Health Care System
Phoenix, Arizona, United States, 85012
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
Center for Clinical Research Castro Valley
Castro Valley, California, United States, 94546
Limb Preservation Platform
Fresno, California, United States, 93721
VA Long Beach Health System
Long Beach, California, United States, 90822
United States, Florida
Miami VA Healthcare System
Miami, Florida, United States, 33125
United States, Massachusetts
MetroWest Medical Center
Framingham, Massachusetts, United States, 01702
United States, South Carolina
Greenville Health System
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
Podimetrics, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Podimetrics, Inc.
ClinicalTrials.gov Identifier: NCT02647346    
Other Study ID Numbers: P-04
First Posted: January 6, 2016    Key Record Dates
Results First Posted: February 5, 2020
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
 Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases