Evaluation of Software Generated Customized Foot Orthoses

July 14, 2025 updated by: University of California, Davis
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 ankle pain.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The investigators 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 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 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 the sponsor to determine whether subjects are using the foot orthoses that the subjects have been provided. Complete primary analysis is estimated to be completed within 3 months after the termination of the study.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95816
        • UC Davis Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Open
Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful Patient Use of a 3D Printed Custom Foot Orthotic
Time Frame: 11 months

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
11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

Soleit

Investigators

  • Principal Investigator: Eric Giza, MD, UC Davis Orthopaedic Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

July 13, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 14, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1771535

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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