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Orthotics
Custom Foot Orthotics for Foot/Ankle Pain
N/A
Waitlist Available
Led By Eric Giza, MD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months to 1 year
Awards & highlights
Study Summary
This trial studies whether custom-made shoe inserts reduce pain for people with foot/ankle pain.
Who is the study for?
This trial is for adults aged 18-65 with foot or ankle pain due to conditions like flat feet, high arches, or other specific diagnoses. They must have a BMI between 18.5 and 30. People who've had recent lower limb surgery, already use custom orthoses, or have active ulcers related to diabetes can't participate.Check my eligibility
What is being tested?
The study is testing if custom-made foot orthotics help reduce pain in individuals with arthritis or other painful conditions of the ankle or foot. Participants will receive personalized shoe inserts designed based on software analysis.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort from improper fit, skin irritation at contact points with the orthotic device, and possible worsening of symptoms if the orthosis doesn't align well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Successful patient use of a 3D printed Custom foot orthotic
Trial Design
1Treatment groups
Experimental Treatment
Group I: OpenExperimental Treatment1 Intervention
Each participant will be evaluated at baseline, when the customized foot orthoses will be made, and the corresponding tests will be conducted.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
custom foot orthotic
2022
N/A
~60
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
914 Previous Clinical Trials
4,720,778 Total Patients Enrolled
SoleitUNKNOWN
Eric Giza, MDPrincipal InvestigatorUC Davis Orthopaedic Surgery
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Open
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I become an enrollee of this clinical experiment?
"This clinical trial is looking for 60 participants who are aged 18 to 65 and possess ankle or feet arthropathy. To be considered, applicants must satisfy these two criteria."
Answered by AI
Is this trial currently accepting participants?
"The clinicaltrials.gov page indicates that this medical study is not actively accepting patients, as the last update was on June 16th 2023. Nonetheless, there are 115 other trials with open recruitment at present."
Answered by AI
Is there an age requirement for participants of this research endeavor?
"This trial is seeking individuals between the age of 18 and 65 to participate in this experiment."
Answered by AI
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