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Evaluation of Software Generated Customized Foot Orthoses

Primary Purpose

Arthropathy of Ankle or Foot

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
custom foot orthotic
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arthropathy of Ankle or Foot

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UC Davis Health

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open

Arm Description

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

Outcomes

Primary Outcome Measures

Successful patient use of a 3D printed Custom foot orthotic
Patient use of foot orthotic

Secondary Outcome Measures

Full Information

First Posted
April 27, 2022
Last Updated
June 16, 2023
Sponsor
University of California, Davis
Collaborators
Soleit
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1. Study Identification

Unique Protocol Identification Number
NCT05462912
Brief Title
Evaluation of Software Generated Customized Foot Orthoses
Official Title
Evaluation of Software Generated Customized Foot Orthoses
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Soleit

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Ankle or Foot

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each 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)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open
Arm Type
Other
Arm Description
Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted.
Intervention Type
Device
Intervention Name(s)
custom foot orthotic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Successful patient use of a 3D printed Custom foot orthotic
Description
Patient use of foot orthotic
Time Frame
6 months to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Giza, MD
Organizational Affiliation
UC Davis Orthopaedic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Software Generated Customized Foot Orthoses

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