Evaluation of Software Generated Customized Foot Orthoses
Phase: NA
Conditions: Arthropathy of Ankle or Foot
Sponsor: University of California, Davis

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Title:  [1771535-1] Evaluation of Software Generated Customized Foot 
Orthoses 
Protocol Version Date: 24 August 2021 
1) Objectives 
Purpose of the Study: 
The purpose of this study is to determine whether custom-made foot 
orthoses generate a significant decrease in the perception of pain among 
individuals with foot pain and/or pathology. 
Secondary: 
1. 
To determine whether custom-made foot orthoses generate a 
significant increase in comfort among individuals with foot pain and/or 
pathology. 
2. 
To determine whether custom-made foot orthoses improve quality 
of life among individuals with foot pain and/or pathology.  
2) Background 
Foot orthoses, or orthotics, are prefabricated or custom-made devices that are 
inserted into shoes to alleviate load and provide cushioning of feet. Prefabricated 
foot orthoses are also known as “over-the-counter” orthotics and are mass-
produced. Custom-made foot orthoses are contoured to an individual’s feet [1].   
 
In general, literature has not been consistent in determining the ideal way in which 
foot orthoses should be customized and fabricated. Results of studies comparing the 
effectiveness of prefabricated versus customized foot orthoses show very 
heterogeneous results, created a large gap in literature. Thus, the current evidence 
on this subject is quite limited, especially when analyzing the effects of foot 
orthoses in people without pathologies, since evidence in this group is even scarcer 
[2, 3]. 
 
Foot orthoses have proven to be useful in pain management [4, 5, 6, 7], in non-
contact injuries [8, 9] and in overuse pathologies in distal and proximal segments of 
the lower extremities, as well as in their prevention [10, 11, 12]. In a study that 
assessed pain in patients with rheumatoid arthritis and forefoot pain, the use of 
custom-made foot orthoses significantly decreased forefoot pain while walking 
[13]. In another study comparing custom and non-custom-made foot orthoses, 
forefoot pain was found to be better relieved by custom-made orthoses than the 
standard ones [14]. Custom-made foot orthoses can be tailored to specific foot 
pathologies, as in pain reduction due to the increase in soles pressures in patients 
affected by rheumatoid arthritis, hallux abductus valgus and secondary 
metatarsalgia [7]. Custom-made foot orthoses were also useful in shifting pressure 

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off painful areas in patients with intermetatarsal bursitis, reducing pain and 
disability, which was supported by ultrasound findings [15].  
 
The literature has been consistent in pointing out the positive effects of foot 
orthoses on comfort in the short term. For example, studies such as that of Tarrade 
et al [16] found significant improvements in the pain of workers who remained 
standing for long periods of time when using foot orthoses. However, the medium 
to long term evidence for this is still not very clear. Among the scarce evidence on 
this subject, García-Hernández et al. [17] demonstrated that manufacturing workers 
showed greater comfort after a period of adaptation, which occurred between one 
and two months after starting the use of foot orthoses. Carrying out this process, 
using modern, tailor-made manufacturing systems could mean better results, as 
these methods have proven to be the most effective in generating foot orthoses. 
 
Though the shape of people’s feet varies from person to person, currently typical 
shoes have inside standard foot orthoses that do not provide customized designs to 
fit the differences in shape of the foot of each person who uses them. This generates 
a wide range of loading and pressure distribution along the sole. This can generate 
pain and a reduced quality of life in the people who use them. Today we have the 
possibility of designing foot orthoses tailored to each person's foot, which generates 
a support and impacts absorption according to the shape of one’s foot, which would 
allow us to generate greater comfort and thus avoid discomfort and injuries caused 
by the alteration of the loads.The goal of this study is to find out whether the use of 
software generated custom-made orthopedic foot orthoses improves pain in the long 
term. 
 
3) Inclusion and Exclusion Criteria 
The attending orthopaedic foot and ankle surgeons will identify patients based on 
clinical exam and/or radiographic findings. Screening and eligibility will be 
conducted by the research coordinator.   
 
Inclusion Criteria: 
1. Foot/ankle pain or pathology OR diagnosed pes planus, pes cavus, pronator 
foot, supinator foot, metatarsalgia, Morton's neuroma, sesamoiditis, hallux 
valgus, intermetatarsal bursitis. 
2. Between 18 and 65 years of age 
3. BMI is greater than 18.5 or less than 30. 
 
Exclusion Criteria: 
1. Individuals who have had surgery in the lower limbs during this past year. 
2. Individuals who already have custom-made orthopedic orthoses. 
3. Patients with active diabetic ulcers or chronic foot pressure ulcers. 
 
4) Study Timelines 
We aim to enroll up to 60 participants over the course of 1-3 months. Each 
participant will be evaluated at baseline, when the customized foot 

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orthoses will be made, and the corresponding tests will be conducted. 
Subsequently, consecutive surveys will be carried out at 0, 7, 30, 120, and 
360 days. days from the first day of foot orthoses use to measure the 
change in pain and comfort with use of the foot orthoses. An interim 
analysis will be conducted after all subjects have completed the 30-day 
time point. This interim analysis will allow us to determine whether 
subjects are using the foot orthoses they have been provided. Complete 
primary analyses is estimated to be completed within 3 months after the 
termination of the study.  
5) Study Endpoints 
Primary endpoint: Successful patient use of a 3D printed custom orthotic 
for at least 6 months and up to 1 year 
6) Secondary endpoint: Improvement in patient report outcomes after 
the use of a 3D printed custom orthoticProcedures Involved 
The evaluation will have a duration of approximately 30 minutes, which 
consists of four stages: 
a. 
Collection of personal data and anamnesis: The patient's 
demographic data, anthropometric measurements and 
anamnesis will be consulted.  
b. 
Physical examination: Visual and palpatory inspection of 
the foot.  
c. 
Baropodometry: Taking of plantar pressures by means of a 
platform. 
i. Static: Subjects should remain standing on the platform 
measuring plantar pressures for 15 seconds with arms at 
the sides and looking straight ahead. There is only 1 
sample. 
ii. Dynamic:  
1. Walking: Subjects should walk over the pressure 
measurement platform. Five shots per foot, with a 
protocol of 5 steps to reach the platform. 
 
d.  
Hindfoot photography: A photograph of the hindfoot will be 
taken, which allows us to measure the angulation of the hindfoot. 
Making and Delivery of Foot Orthoses: 
During a period of 2 weeks, the foot orthoses will be created using Soleit 
software which will later be manufactured via three-dimensional printing. 
Use of Foot Orthoses: 
Foot orthoses will be sent to participants along with a small instruction 
manual and protocol of use. When using the foot orthoses for the first 

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time, participants must navigate to a specific link to begin monitoring their 
foot orthoses use. The link will be sent prior to receiving the foot orthoses. 
Participants should use the foot orthoses progressively for a period of 1 
week. The first week will be an adaptation week in which participants 
should use the foot orthoses for 1 hour on the first day, then increase use 
by 1 hour each day until reaching 4 consecutive hours at which time the 
foot orthoses can be worn continuously.  
Follow-Up and Questionnaires:  
Participants will be sent surveys on three occasions—0, 7, 30, 120, and 
360 days from the start of use of their foot orthoses. The survey will 
primarily evaluate a 9-item scale that measures the comfort generated by 
the foot orthoses. The survey completed at day 0 and 30 will serve to 
evaluate the comfort of the foot orthoses. The survey sent on day 7 will be 
used to evaluate the tolerance of the new foot orthoses.  
• Pain Visual Analog Scale (VAS) – Rates the intensity of pain from 0 – 10 
with 10 being the worst pain possible.  
• EuroQol 5D – Rates the quality of life including mobility, self-care, usual 
activities, pain/discomfort, and anxiety/depression. The scale ranges from 
0 to 100, with 100 indicating the best health imaginable.   
• Foot Health Status Questionnaire – Measures foot pain and function, 
general foot health, and perception of footwear. The scale ranges from 0 to 
100, with 100 indicating the best foot health.   
Adverse Events: 
Because this study is subjective in nature, only adverse events that are 
serious, unexpected, and device-related will be recorded. Collection of 
adverse events will begin once subject begins using the foot orthoses. All 
adverse events will be monitored and reported in accordance with the UC 
Davis Institutional Review Board (IRB) policies. 
7) Data and/or Specimen Management and Confidentiality 
☒ I understand that if this study involves the use of  the UC Davis Health 
Electronic Health Record (EMR/EPIC) also contains the clinical data for 
Marshall Medical Center (MMC). I understand that MMC patient data 
cannot be accessed for research purposes and that I must take the 
necessary steps to ensure that MMC data is not accessed, used, or 
disclosed for UC Davis Health research purposes. 
☒ I undersand that if this study involves use of UC Davis students’ 
educational records (including records in the PI’s own possession such as 
course exams/assignments), I must consult with the Registrar’s office to 
see if all requirements of the Family Educational Rights and Privacy Act 
(FERPA) are satisfied.   
Data Analysis & Statistical Considerations:   

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A quasi-experimental, within-subject (repeated measures) and longitudinal 
controlled design will be established. Patients will be recruited from the 
patient population at the University of California, Davis Orthopaedic Foot 
and Ankle Clinic. From the total number of enrolled subjects who meet 
the inclusion criteria, an optimal N of 52 subjects will be randomly 
selected, considering a medium effect size (0.4) and a p less than 0.05 to 
achieve a statistical power of 0.8. Being a longitudinal study, a sample 
loss of 10% was established. Therefore, 60 subjects will be included in the 
study. We aim to enroll up to 60 participants over the course of 1-3 
months.   
Intra-subject pain, comfort, and quality of life averages pre-use and post 
use of the foot orthoses will be compared. The sample of participants will 
be described with central tendency statistics and baseline parameters, and 
post use evaluations (0, 7, and 30, 120, and 360 days after first foot 
orthoses use) will be established. These will be compared to study possible 
differences. For normally distributed dataions, repeated measures,one-way 
ANOVAnova for paired samples will be used for normal distributions  
will be used with a Tukey's post-test and in case of non-normal 
distributions, Friedman's test will be used with a Dunn's post-test. All 
analyses will be performed with the SPSS statistical package. 
Privacy, Data Storage & Confidentiality:   
All study data, such as forms, reports, and other records, including 
electronic records, will be identified by a coded number to maintain 
patient confidentiality and will only be accessible by members of the 
research team. Paper records will be kept in locked file cabinets in locked 
rooms. Electronic data will be located on computers containing a log-on 
and password. Written permission from the participant must be obtained 
prior to the release of clinical information, except as necessary for 
monitoring by the IRB. All communication, consent procedures, forms, 
and storage of patient data will be maintained and stored in accordance 
with the UC Davis’ IRB, Good Clinical Practices requirements, and the 
Health Insurance Portability and Accountability Act. All personnel 
involved with the study are required to complete the Protection of Human 
Subjects training.  
Due to the complexity of the software, it will only be used by a trained 
kinesiologist belonging to the Soleit team. 
Although the evaluating kinesiologist will have access to all the 
volunteers' data temporarily in order to carry out the correct control and 
follow-up work, three independent databases will be maintained to 
guarantee the confidentiality of the information: 
a. 
Identification data: Data allowing identification of patients will be 
kept in Excel listing, handled by the study investigators. 

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b. 
Biomechanical data: The data corresponding to pressure 
measurements, medical history and images are essential for the automated 
design of the foot orthoses and will be managed anonymously, without 
any participant identifiers, in the Soleit software. 
c. 
Tracking Data: Tracking forms for recording the effectiveness of 
the foot orthoses will be managed independently via surveymonkey.com 
and will be anonymously transmitted, without any participant identifiers, 
to the principal investigator after which the surveymonkey.com service 
will be cancelled, and the data deleted. 
At the end of the evaluation, all data will be anonymized and delivered to 
the researcher responsible for statistical analysis. 
8) Data and/or Specimen Banking 
Address the last bullet point if you answered “Yes” to tissue banking 
within the Initial Application Form. 
If data will be banked for future uses address the following questions: 
 
• 
What data will be banked? 
• 
What identifiers will be included in that data? 
• 
For what purpose will the data be used? 
• 
Where and how will data be stored? 
• 
How long will the data be stored? 
• Describe the procedures to release data, including: the process to 
request a release, approvals required for release, who can obtain 
data or specimens, and the data to be provided with specimens. 
9) Provisions to Monitor the Data to Ensure the Safety of Subjects 
As this is a minimal risk study, no data and safety monitoring (DSMB) 
will be used.  Microsoft Excel will be used to manage data used. Sponsor 
will conduct an ongoing monitoring of study conduct and safety data. 
The following will be reported within 10 calendar days, except when 24-
hour reporting is specified: 
1. Information that indicates a change to the risks of potential benefits of 
the human research: 
a. An interim analysis, safety monitoring report, publication in the 
literature, or revised investigator brochure that indicates an increase in the 
frequency or magnitude of a given harm, uncovers a new risk, or provides 
more information about the benefits of the human research. 
b. Change in FDA labeling or withdrawal of the device from the market. 
c. Protocol deviation that harmed participants or indicates participants 
might be at increased risk of harm. If the protocol deviation was made in 

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order to eliminate an apparent immediate hazard to a participant, the PI 
must submit the information within 24 hours. 
d. Complaint of a participant that indicates participants or others might be 
at increased risk of harm or at risk of a new harm. 
2. Any adverse event experienced by a participant of other individual, 
which is both unexpected and at least probably related to the human 
research device. 
a. A harm is “unexpected” when its specificity and severity are not 
accurately reflected in the consent document. 
b. A harm is “at least probably related” if the research device more likely 
than not caused the harm. 
c. Timeline Exception: If the unexpected and at least probably related 
harm is death of a research subject, the PI must report the information 
within 24 hours. 
3. Finding of Non-Compliance or Allegation of Non-Compliance. 
4. Protocol Deviations: Failure to follow the protocol due to the action or 
inaction of the investigator or research staff. Exception – If the protocol 
deviation was taken in order to eliminate an apparent immediate hazard to 
a participant, the PI must report the information within 24 hours. 
5. Breach of confidentiality: must be reported within 24 hours. 
6. Change to protocol taken without prior IRB review to eliminate an 
apparent immediate hazard to a participant: must be reported within 24 
hours. 
7. Complaint of a participant that cannot be resolved by the research team. 
8. Unanticipated adverse device effect. Exception – if the unexpected and 
at least probably related adverse device effect results in the death of a 
research subject, the PI must report the information within 24 hours. 
All data collected will remain confidential. Data will be stored securely 
under the patient’s study identification number. All clinical data, images 
and surgical/procedural data will be de-identified prior to any in-house or 
public presentation of data or images. Coded data will only be released to 
those listed as study investigators or support staff. Paper data records will 
be stored in locked file cabinets in a locked office. All electronic research 
data will be stored on the PI computer that is password protected and 
encrypted. 
IRB, FDA and any applicable regulatory agencies will have access to the 
study records upon request. The data and associated identifiers will be 
kept for up to 5 years in a locked research facility accessible only to 
designated personnel, at which time the data will be destroyed per hospital 
policy. If the results of this study are published, the data will be reported 

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collectively without mention of any subject’s identity, thereby ensuring 
subject anonymity. 
10) Withdrawal of Subjects 
Subjects may withdraw from the study at any time. Subjects may be 
withdrawn by an investigator if the participant does not participate in 
study follow-ups. Research staff will document the reason for withdrawal. 
Subjects who fail to appear at initial visit or do not receive the foot 
orthoses will be considered screen failures and will be removed from the 
study and the study data. 
11) Risks to Subjects 
 
Risk Assessment and Device-Related Risks:  
 
Discomfort: 
A conceived device-related risk is that the foot orthoses cause discomfort. 
This will be controlled in two ways. The first is that the use of the foot 
orthoses will be done progressively. This means that participants should 
use the foot orthoses for 1 hour on the first day, then increase use by 1 
hour each day until reaching 4 consecutive hours at which time the foot 
orthoses can be worn continuously. Any discomfort should be reported to 
the nurse practitioner in charge and will be reviewed to assess if a new 
foot orthosis with the appropriate modifications should be made or if the 
use of the foot orthoses should be discontinued. 
Blisters: 
Another conceived device-related risk is the generation of blisters due to 
friction. If a participant is found to experience an area of increased 
rubbing that could lead to a blister, the participant should discontinue the 
use of the foot orthoses immediately. In addition, as a part of protocol, 
participants should inspect the soles of their feet when they finish any type 
of physical activity and check for any areas of redness as a result of the 
use of the foot orthoses. If any redness is present, inform the nurse 
practitioner who will assess if new foot orthoses with the appropriate 
modifications should be made or if the use of the foot orthoses should be 
discontinued. 
12) Potential Benefits to Subjects 
Participants will receive custom-made foot orthoses free of charge. No 
additional compensation will be received.  
13) Sharing of Results with Subjects 
  N/A  Results will not be shared with patients. 
 

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14) Provisions to Protect the Privacy Interests of Subjects 
As part of the consent process, the patients will be informed about the nature of 
the data that will be collected, how the information will be collected and who will 
have access to the information and how it will be stored. The information will be 
handled initially by the clinical and research team at the collecting institution and 
only shared with the data hub institution UC Davis in a deidentified format.  
. 
15) Economic Burden to Subjects 
The only anticipated cost is transportation to the clinic during the initial 
visit. There will be no cost to the subjects for the manufacturing of the 
foot orthoses. The non-standard of care foot orthoses will be paid for by 
Soleit.  
16) Drugs or Devices 
If the research involves drugs or device, describe your plans to store, 
handle, and administer those drugs or devices so that they will be used 
only on subjects and be used only by authorized investigators. N/A 
☐ I confirm that all investigational drugs will be received by the Investigational 
Drug Service (IDS).  The IDS will store, handle, and administer those drugs so 
that they will be used only on subjects and be used only by authorized 
investigators. 
 
☐ I confirm that all investigational devices will be labelled in accordance with 
FDA regulations and stored and dispensed in such a manner that they will be 
used only on subjects and be used only by authorized investigators. 
 
17) Review Requirements 
        Are there any contractual obligations or other considerations that 
require IRB review of this research, or review at intervals other 
than those required by the Common Rule or FDA? If yes, check 
box: 
 
☐  Yes 
 
☒ No 
 
 
References: 
1.  Tran K, Spry C. Custom-Made Foot Orthoses versus Prefabricated foot Orthoses: A 
Review of Clinical Effectiveness and Cost-Effectiveness [Internet]. Ottawa (ON): 

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https://www.ncbi.nlm.nih.gov/books/NBK549527/ 
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