Evaluation of Software Generated Customized Foot Orthoses

Not Applicable

Terminated

• Conditions: Arthropathy of Ankle or Foot
• Interventions: Device: custom foot orthotic

• Registration Number: NCT05462912
• Lead Sponsor: University of California, Davis

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.

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 Timeline

• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-18
• Study Start: 2022-10-01
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open	custom foot orthotic	Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted.

Primary Outcome Measures

Name	Time	Method
Successful patient use of a 3D printed Custom foot orthotic	6 months to 1 year	Patient use of foot orthotic

Trial Locations

Locations (1)

UC Davis Health; 🇺🇸 Sacramento, California, United States