Evaluation of Software Generated Customized Foot Orthoses

Arthropathy of Ankle or Foot Clinical Trial

Official title:

Evaluation of Software Generated Customized Foot Orthoses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05462912
• Other study ID #: 1771535
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: June 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthropathy of Ankle or Foot
• Joint Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	UC Davis Health	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Soleit

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful patient use of a 3D printed Custom foot orthotic	Patient use of foot orthotic	6 months to 1 year