PopSole™ Offloading Device for Plantar Fasciitis (PopSole2 Trial)

N/A

Waitlist Available

Led By Jeffrey Gusenoff, MD

Research Sponsored by Jeffrey A. Gusenoff, MD

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 four weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new shoe insert called PopSole™ that helps people with foot pain by reducing pressure on sore spots and providing better support. PopSole™ is a novel foot offloading device designed to provide customizable pain relief and support for individuals with foot pain. Participants will use the insert for a period to see if it improves their pain and comfort.

Eligible Conditions

Fat Pad Syndrome
Plantar Fasciitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ four weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~four weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and four 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 From Screening/Baseline Visit to 4 Week Visit as Reported on the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale.

Change in Foot Pain From Screening/Baseline Visit to 4 Week Visit as Reported on the Manchester Foot and Ankle Index.

Foot

+3 more

Secondary study objectives

Participants' Reported Satisfaction and/or Difficulties With the Device

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PopSole™ offloading deviceExperimental Treatment1 Intervention

This is an external insole device that fits into a shoe and is reusable for a given subject, not for one-time use. It is comparable to other off-the-shelf insoles readily available and presents minimal risk to the participant during the four weeks of study participation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PopSole™ Offloading Device

2020

N/A

~20

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