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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

PopSole2 Trial Summary

This trial is testing a new device to help with foot pain, by customizing support and elevation. They will use validated patient reported outcome measures to assess the improvement of pain over a 4 week period.

Eligible Conditions
  • Fat Pad Syndrome
  • Plantar Fasciitis

PopSole2 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Participants' Reported Satisfaction and/or Difficulties With the Device

PopSole2 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of Bodywork and Movement TherapiesJournal
Compliance of Patients Wearing an Orthotic Device or Orthopedic Shoes: A Systematic Review
Swinnen, Eva, and Eric Kerckhofs. 2015. “Compliance of Patients Wearing an Orthotic Device or Orthopedic Shoes: A Systematic Review”. Journal of Bodywork and Movement Therapies. Elsevier BV. doi:10.1016/j.jbmt.2015.06.008.
Prosthetics & Orthotics InternationalJournal
Orthotic Management of the Neuropathic Foot
Robinson, Christopher, Matthew J Major, Charles Kuffel, Kevin Hines, and Pamela Cole. 2015. “Orthotic Management of the Neuropathic Foot”. Prosthetics & Orthotics International. Ovid Technologies (Wolters Kluwer Health). doi:10.1177/0309364614545422.
Gait & PostureJournal
Effects of the Twin Shoe (darco) to Compensate Height Differences in Normal Gait
Wünnemann, Martin, Dieter Klein, and Dieter Rosenbaum. 2011. “Effects of the Twin Shoe (darco) to Compensate Height Differences in Normal Gait”. Gait & Posture. Elsevier BV. doi:10.1016/j.gaitpost.2010.09.025.
Diabetes CareJournal
Adherence to Wearing Prescription Custom-made Footwear in Patients with Diabetes at High Risk for Plantar Foot Ulceration
Waaijman, Roelof, Renske Keukenkamp, Mirjam de Haart, Wojtek P. Polomski, Frans Nollet, and Sicco A. Bus. 2013. “Adherence to Wearing Prescription Custom-made Footwear in Patients with Diabetes at High Risk for Plantar Foot Ulceration”. Diabetes Care. American Diabetes Association. doi:10.2337/dc12-1330.
~4 spots leftby Apr 2025
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