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Orthopedic Device

Therapeutic Shoes for Plantar Fasciitis

N/A
Recruiting
Research Sponsored by University of Texas Rio Grande Valley
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Not engaged in any physician prescribed treatment plan
Be older than 18 years old
Must not have
Patients with plantar ulcer
Patients with major foot deformities such as charcot foot, pes cavus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

"This trial is looking at how well OrthoFeet Hands-Free therapeutic shoes and prefabricated inserts work for people with foot pain."

Who is the study for?
This trial is for individuals who can consent, have normal foot sensation, and self-reported foot pain not currently under a treatment plan. It excludes those with swelling, ulcers, major foot deformities or amputations, cognitive impairments or depression, unstable medical conditions, decreased foot sensation, or those treating their foot pain.
What is being tested?
The study tests the effectiveness of OrthoFeet HandsFree therapeutic shoes with inserts in reducing foot pain and pressure. Participants will use these specialized shoes to see if they help relieve discomfort associated with plantar fasciitis.
What are the potential side effects?
While specific side effects are not listed for wearing therapeutic shoes and inserts, some may experience discomfort or skin irritation due to new footwear adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not currently following any doctor-prescribed treatment plans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an ulcer on the bottom of my foot.
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I have significant foot deformities like charcot foot or high arches.
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I have had an amputation on my lower limb.
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I have reduced feeling in my legs.
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I have foot pain due to a nail condition or hard skin lesions.
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I currently have a broken foot.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Foot pain
In-shoe Peak Plantar pressure
Pressure-Time Integral
Secondary study objectives
Physical activity
Quality of life

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: OrthoFeet shoeExperimental Treatment1 Intervention
Patients wearing OrthoFeet shoes with standard inserts
Group II: Own ShoeActive Control1 Intervention
Patients wearing their own appropriate shoes

Find a Location

Who is running the clinical trial?

University of Texas Rio Grande ValleyLead Sponsor
7 Previous Clinical Trials
2,625 Total Patients Enrolled
~33 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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