Evaluation of Software Generated Customized Foot Orthoses

Sponsor

University of California, Davis (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05462912

Collaborator

Soleit (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arthropathy of Ankle or Foot	Device: custom foot orthotic	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Evaluation of Software Generated Customized Foot Orthoses

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Successful patient use of a 3D printed Custom foot orthotic [6 months to 1 year]
Patient use of foot orthotic

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of California, Davis
Soleit

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, Davis

ClinicalTrials.gov Identifier:

NCT05462912

Other Study ID Numbers:

1771535-1

First Posted:

Jul 18, 2022

Last Update Posted:

Jul 18, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Joint Diseases

Study Results

No Results Posted as of Jul 18, 2022