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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 Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Foot Ulcer, Diabetic
Intervention Device: Daily use of podimetrics smart-foot mat
Enrollment 132
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Participant Cohort
Hide Arm/Group Description Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
Period Title: Overall Study
Started 132
Completed 129
Not Completed 3
Arm/Group Title Participant Cohort
Hide Arm/Group Description Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
Overall Number of Baseline Participants 129
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants
<=18 years
0
   0.0%
Between 18 and 65 years
55
  42.6%
>=65 years
74
  57.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 129 participants
65  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants
Female
18
  14.0%
Male
111
  86.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Racial Origin Number Analyzed 129 participants
African American
19
  14.7%
American Indian
1
   0.8%
Asian
2
   1.6%
Caucasian
76
  58.9%
Hispanic/Latino
26
  20.2%
Native American
3
   2.3%
Unspecified
2
   1.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 129 participants
129
1.Primary Outcome
Title Occurrence of Plantar Diabetic Foot Ulcer
Hide Description [Not Specified]
Time Frame Through study completion or subject withdrawal (34 weeks per-protocol)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participant Cohort
Hide Arm/Group Description:
Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
Overall Number of Participants Analyzed 129
Measure Type: Count of Participants
Unit of Measure: Participants
37
  28.7%
2.Secondary Outcome
Title Subject Adherence in Daily Use of the Study Device
Hide Description [Not Specified]
Time Frame Through study completion or subject withdrawal (34 weeks per-protocol)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participant Cohort
Hide Arm/Group Description:
Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
Overall Number of Participants Analyzed 129
Mean (Standard Deviation)
Unit of Measure: uses/week
5.5  (1.2)
3.Secondary Outcome
Title Device-related Trips/Falls
Hide Description [Not Specified]
Time Frame Through study completion or subject withdrawal (34 weeks per-protocol)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participant Cohort
Hide Arm/Group Description:
Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
Overall Number of Participants Analyzed 132
Measure Type: Number
Unit of Measure: occurence
0
4.Secondary Outcome
Title Device-related Injuries
Hide Description [Not Specified]
Time Frame Through study completion or subject withdrawal (34 weeks per-protocol)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participant Cohort
Hide Arm/Group Description:
Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
Overall Number of Participants Analyzed 132
Measure Type: Number
Unit of Measure: occurence
0
Time Frame 34 weeks
Adverse Event Reporting Description Per the original definition of adverse event in the protocol, diabetic foot ulcer occurrence does not constitute as an adverse event.
 
Arm/Group Title Participant Cohort
Hide Arm/Group Description Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
All-Cause Mortality
Participant Cohort
Affected / at Risk (%)
Total   3/132 (2.27%) 
Hide Serious Adverse Events
Participant Cohort
Affected / at Risk (%)
Total   0/132 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participant Cohort
Affected / at Risk (%)
Total   0/132 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Brian Petersen
Organization: Podimetrics Inc
Phone: 860-558-9204
EMail: brian@podimetrics.com
Layout table for additonal information
Responsible Party: Podimetrics, Inc.
ClinicalTrials.gov Identifier: NCT02647346    
Other Study ID Numbers: P-04
First Submitted: January 4, 2016
First Posted: January 6, 2016
Results First Submitted: January 14, 2020
Results First Posted: February 5, 2020
Last Update Posted: February 21, 2020