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Offloading Device

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

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 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

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

Find a Location

Who is running the clinical trial?

Jeffrey A. Gusenoff, MDLead Sponsor
1 Previous Clinical Trials
Jeffrey Gusenoff, MDPrincipal InvestigatorProfessor of Plastic Surgery, Director of the Foot Fat Grafting Institute
1 Previous Clinical Trials
10 Total Patients Enrolled
~4 spots leftby Sep 2025
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