Evaluation of Software Generated Customized Foot Orthoses

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Software Generated Customized Foot Orthoses

Conditions
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Arthropathy of Ankle or Foot

Intervention / Treatment
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* Device: custom foot orthotic


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful patient use of a 3D printed Custom foot orthotic | Patient use of foot orthotic | 6 months to 1 year |