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Footwear

Orthofeet: A Prospective Proof of Concept Trial to Evaluate an Innovative Pain Relief Footwear

Phase 1 & 2
Waitlist Available
Research Sponsored by Bijan Najafi, PhD
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 baseline, 1 week, 6 weeks, 7 weeks, 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial tests special shoes called Orthofeet on adults aged 50+ with significant foot pain. The shoes have adjustable insoles to reduce foot pressure and pain, aiming to improve daily activities and overall well-being.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 week, 6 weeks, 7 weeks, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week, 6 weeks, 7 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
Change in Foot Pain Intensity
Change in step count from baseline to 6 weeks to 12 weeks
Secondary study objectives
Change in Balance
Change in Cognitive Function
Change in Fear of Falling
+3 more

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 ShoesExperimental Treatment1 Intervention
Participants will be given Orthofeet shoes to wear for 6 weeks
Group II: No Orthofeet shoesActive Control1 Intervention
This group will not be wearing Orthofeet shoes for 6 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Orthofeet Shoes
2022
Completed Phase 2
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Bijan Najafi, PhDLead Sponsor
4 Previous Clinical Trials
284 Total Patients Enrolled
Orthofeet, Inc.UNKNOWN
~15 spots leftby Dec 2025
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