CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
PopSole™ Offloading Devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04378270
NCT04378270N/ACompleted
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Validation of a Novel Foot Offloading Device

Jeffrey A. Gusenoff, MD·interventional·Posted May 7, 2020·Updated Jan 31, 2024

In Brief

A clinical study evaluating PopSole™ Offloading Device for Plantar Fasciitis, Chronic and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Pressure offloading is often considered the most crucial aspect in healing after a foot injury. The investigators have devised a novel foot offloading device (PopSole™) which will allow for customization of the area where there is foot pain, as well as allow for customizable arch support and elevation of the metatarsals. This validation study is aimed to assess improvement of pain with use, ease of use, fit and feel, compliance, and durability over a 4 week period. Validated patient reported outcome measures will be used at baseline, 2 weeks and 4 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlantar Fasciitis, Chronic, Heel Pain Syndrome, Fat Pad Syndrome
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMay 7, 2020
Enrollment StartAug 26, 2020
Primary CompletionOct 20, 2021
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.2 years ago

Interventions

PopSole™ Offloading Devicedevice

Specifically, the PopSole™ Offloading Device allows the provider to pop bubbles in the device (like popping paper or plastic bubble sheeting), thereby offloading the surgical area or area of pain. This customizable approach to offloading may increase compliance as it can easily fit in a normal walking shoe and is personalized for each patient. It can also be attached to a slide for use in the shower. Currently no post-operative devices for offloading the foot can be used in the shower.