Trial Outcomes & Findings for Evaluation of Software Generated Customized Foot Orthoses (NCT NCT05462912)

Last Updated: 2025-08-01

Results Overview

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

Recruitment status

TERMINATED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

11 months

Results posted on

2025-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	Open Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted. custom foot orthotic: 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.
Overall Study STARTED	60
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	60

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Software Generated Customized Foot Orthoses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open n=60 Participants Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted. custom foot orthotic: 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	45 years n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	60 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 11 months

Population: A random sampling of subjects presenting with the condition being studied

Outcome measures

Outcome measures
Measure	Open n=60 Participants Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted. custom foot orthotic: 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. 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.
Successful Patient Use of a 3D Printed Custom Foot Orthotic	60 participants

Adverse Events

Open

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eric Giza, MD

UC Davis Orthopaedic Surgery

Phone: 916-734-6805

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place