NCT05462912

Evaluation of Software Generated Customized Foot Orthoses

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Arthropathy of Ankle or Foot

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2022-07-18
• Last updated: 2025-08-01
• Results posted: 2025-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study