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Peak Plantar Pressures While Wearing a Carbon Fiber Off Loading Orthoses (CFO)

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ClinicalTrials.gov Identifier: NCT03618628
Recruitment Status : Completed
First Posted : August 7, 2018
Results First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Mary Hastings, PT, DPT, ATC, Washington University School of Medicine

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Diabetes Mellitus
Peripheral Neuropathy
Orthotic Device
Intervention Device: Carbon Fiber Off Loading Orthosis (CFO)
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title People Using a CFO
Hide Arm/Group Description

People who are currently wearing a carbon fiber off loading orthosis (CFO) will have a new CFO fabricated for them based on the results of our finite element (FE) model. We will then test both CFOs ability to reduce peak plantar compared to barefoot and the peak plantarflexor power of both braces.

Carbon Fiber Off Loading Orthosis (CFO): A finite element (FE) model will be created to determine properties that will improve CFO strength while maintaining reduction of peak plantar pressures of the CFO and plantarflexor power. A new CFO will then be fabricated for the participant. Participants will be tested in while walking barefoot, wearing their current CFO, and wearing the FE model driven CFO.

Period Title: Overall Study
Started 3
Completed 1
Not Completed 2
Reason Not Completed
Death             1
Lost to Follow-up             1
Arm/Group Title People Using a CFO
Hide Arm/Group Description

People who are currently wearing a carbon fiber off loading orthosis (CFO) will have a new CFO fabricated for them based on the results of our finite element (FE) model. We will then test both CFOs ability to reduce peak plantar compared to barefoot and the peak plantarflexor power of both braces.

Carbon Fiber Off Loading Orthosis (CFO): A finite element (FE) model will be created to determine properties that will improve CFO strength while maintaining reduction of peak plantar pressures of the CFO and plantarflexor power. A new CFO will then be fabricated for the participant. Participants will be tested in while walking barefoot, wearing their current CFO, and wearing the FE model driven CFO.

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  33.3%
>=65 years
2
  66.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants
66.3  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
2
  66.7%
Male
1
  33.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
3
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  33.3%
White
2
  66.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Peak Plantar Pressure
Hide Description Plantar pressure during walking while the participant wears the brace fabricated based on the finite element (FE) model compared to 1) the brace fabricated based on current clinical standards and 2) barefoot.
Time Frame Participant was tested in new brace (based on FE model) after wearing for 1 week.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title People Using a CFO
Hide Arm/Group Description:

People who are currently wearing a carbon fiber off loading orthosis (CFO) will have a new CFO fabricated for them based on the results of our finite element (FE) model. We will then test both CFOs ability to reduce peak plantar compared to barefoot and the peak plantarflexor power of both braces.

Carbon Fiber Off Loading Orthosis (CFO): A finite element (FE) model will be created to determine properties that will improve CFO strength while maintaining reduction of peak plantar pressures of the CFO and plantarflexor power. A new CFO will then be fabricated for the participant. Participants will be tested in while walking barefoot, wearing their current CFO, and wearing the FE model driven CFO.

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Newtons per squared centimeters
Barefoot (midfoot) 75.3
Current CFO (midfoot) 14.2
Model driven CFO (midfoot) 14.5
Barefoot (Forefoot) 22.8
Current CFO (Forefoot) 3.5
Model driven CFO (Forefoot) 6.6
Barefoot (Heel) 60.0
Current CFO (Heel) 23.4
Model driven CFO (Heel) 14.5
Time Frame Baseline data collected in a brace provided as standard of care. A finite element model was constructed of the brace and provided input for changes in brace construction. This process took 9 months and the participant was tested in the model informed brace 11 months after initial testing
Adverse Event Reporting Description Risks to participants were the possibility of discomfort, blister, or sore while getting used to a new brace and falling during peak plantar pressure testing. Participants were told to contact the study team immediately if any of these they experienced discomfort, blisters, or sores when adapting to the new brace. During peak plantar pressure testing a study team member walked beside the participant holding a gait belt around the waist to make sure they did not fall.
 
Arm/Group Title People Using a CFO
Hide Arm/Group Description

People who are currently wearing a carbon fiber off loading orthosis (CFO) will have a new CFO fabricated for them based on the results of our finite element (FE) model. We will then test both CFOs ability to reduce peak plantar compared to barefoot and the peak plantarflexor power of both braces.

Carbon Fiber Off Loading Orthosis (CFO): A finite element (FE) model will be created to determine properties that will improve CFO strength while maintaining reduction of peak plantar pressures of the CFO and plantarflexor power. A new CFO will then be fabricated for the participant. Participants will be tested in while walking barefoot, wearing their current CFO, and wearing the FE model driven CFO.

All-Cause Mortality
People Using a CFO
Affected / at Risk (%)
Total   1/3 (33.33%) 
Show Serious Adverse Events Hide Serious Adverse Events
People Using a CFO
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
People Using a CFO
Affected / at Risk (%)
Total   0/3 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Mary Hastings
Organization: Washington University School of Medicine
Phone: 3142861433
EMail: hastingsmk@wustl.edu
Layout table for additonal information
Responsible Party: Mary Hastings, PT, DPT, ATC, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03618628     History of Changes
Other Study ID Numbers: 201308105
First Submitted: July 16, 2018
First Posted: August 7, 2018
Results First Submitted: September 17, 2018
Results First Posted: May 13, 2019
Last Update Posted: May 13, 2019