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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.

Tracking Information
First Submitted Date  ICMJE January 4, 2016
First Posted Date  ICMJE January 6, 2016
Results First Submitted Date  ICMJE January 14, 2020
Results First Posted Date  ICMJE February 5, 2020
Last Update Posted Date February 21, 2020
Study Start Date  ICMJE November 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
Occurrence of Plantar Diabetic Foot Ulcer [ Time Frame: Through study completion or subject withdrawal (34 weeks per-protocol) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2020)
  • Subject Adherence in Daily Use of the Study Device [ Time Frame: 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) ]
  • Device-related Injuries [ Time Frame: Through study completion or subject withdrawal (34 weeks per-protocol) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
  • Subject Adherence in Daily Use of the Study Device [ Time Frame: Through study completion or subject withdrawal (34 weeks per-protocol) ]
  • Occurrence of Device Related Trips or Falls [ Time Frame: Through study completion or subject withdrawal (34 weeks per-protocol) ]
  • Occurrence of Device Related Injury (Burn, Electrocution, etc…) [ Time Frame: Through study completion or subject withdrawal (34 weeks per-protocol) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers
Official Title  ICMJE In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Foot Ulcer, Diabetic
Intervention  ICMJE Device: Daily use of podimetrics smart-foot mat
Study Arms  ICMJE Experimental: Participant cohort
Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
Intervention: Device: Daily use of podimetrics smart-foot mat
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2016)
132
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02647346
Other Study ID Numbers  ICMJE P-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Podimetrics, Inc.
Study Sponsor  ICMJE Podimetrics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Podimetrics, Inc.
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP