Evaluation of Software Generated Customized Foot Orthoses

NCT05462912 | Terminated Results DMC FDA Device

• 1 other identifier: 1771535
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthropathy of Ankle or Foot

Outcome Measures

Primary Outcomes (1)

• Successful Patient Use of a 3D Printed Custom Foot Orthotic

  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

Study Arms (1)

Open

OTHER

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

Interventions

custom foot orthotic DEVICE

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.

Open

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Foot/ankle pain or pathology OR diagnosed pes planus, pes cavus, pronator foot, supinator foot, metatarsalgia, Morton's neuroma, sesamoiditis, hallux valgus, intermetatarsal bursitis
• Between 18 and 65 years of age
• BMI is greater than 18.5 or less than 30

You may not qualify if:

• Individuals who have had surgery in the lower limbs during this past year.
• Individuals who already have custom-made orthopedic orthoses.
• Patients with active diabetic ulcers or chronic foot pressure ulcers.

Sponsors & Collaborators

• University of California, Davis: lead
• Soleit: collaborator

Study Sites (1)

UC Davis Health

Sacramento, California, 95816, United States

Location

Limitations and Caveats

Due to significant issues identified in the data collection process the study was terminated prematurely The study required participants to complete a survey at three specific time points: This was not done. The data was not stored and will not be used for any future analysis. No data was evaluated or stored that was collected for this trial. The website where data was originally collected was deleted and not accessible. No data analysis was done.

Results Point of Contact

• Title: Eric Giza, MD
• Organization: UC Davis Orthopaedic Surgery

egiza@ucdavis.edu

916-734-6805

Study Officials

• Eric Giza, MD

  UC Davis Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: July 18, 2022
• Study Start: October 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: August 1, 2025
• Results First Posted: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)