Validation of a Novel Foot Offloading Device (PopSole2)

January 30, 2024 updated by: Jeffrey A. Gusenoff, MD
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All subjects will receive the PopSole™ offloading device at the screening/baseline visit, be asked to wear it for 4 weeks, and will be asked to return for an in-person evaluation at week 2 and a completion study visit at week 4.

Screening includes the following procedures:

  1. Performance of a limited physical exam, inclusive of participant's foot exam with a gait and shoe gear evaluation.
  2. Medical and surgical history collection
  3. Vital signs, medication profile, allergies, height, weight, and BMI calculation.
  4. Collection of demographic information
  5. 2D Photographs of both feet will be performed

Subjects will be asked to complete:

  1. Questionnaires

    • Foot and Ankle Ability Measure questionnaire
    • Mayo Clinical Scoring System questionnaire
    • American Orthopaedic Foot and Ankle Society questionnaire
    • Manchester Foot and Ankle Disability Index
    • Pittsburgh Foot Survey
  2. Diary cards to document for the feet: pain, bruising, redness of the skin, itching, swelling, bleeding, and any concerns/issues not listed, as well as the location, date and day for each noted symptom.
  3. Offload Device Distribution. Devices will be provided for both feet to maintain symmetry and gait stability between the two feet. One pair of devices will be given for use in shoe gear, and one pair will be given for use in a slide in the shower.

Follow up visit procedures:

Week 2

  1. Collection of vital signs, medication profile, weight, and BMI calculation
  2. Limited physical exam with a foot exam
  3. Adverse Event Reporting
  4. Collection and distribution of feet diary cards
  5. 2D Photographs of both feet
  6. Foot Assessment Questionnaires
  7. Device survey - questions about the fit and feel of the device

Week 4

The same procedures listed for week 2, with the addition of PopSole™ Device removal and final foot diary card collection.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Aesthetic Plastic Surgery Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 years or older and able to provide informed consent
  2. Subjects with foot pain due to forefoot or heel fat pad atrophy or chronic plantar fasciitis as defined by heel pain for greater than 6 months and failed non-surgical therapy
  3. Willing and able to comply with follow up examinations

Exclusion Criteria:

  1. Concurrent injury to the lower extremity that would effect gait
  2. Open foot ulcerations, fractures, or diagnosis of osteomyelitis of the feet
  3. Surgical foot intervention in the last 6 months
  4. Diagnosis of pregnancy or the intent of the participant to become pregnant during participation in this study
  5. Neuropathy
  6. Any issue that per the physician's determination would render the patient not appropriate to continue participation in the study (compliance, change in physical status, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PopSole™ offloading device
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.
Device: PopSole™ Offloading Device
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Foot Pain From Screening/Baseline Visit to 4 Week Visit as Reported on the Pittsburgh Foot Survey.
Time Frame: Four Weeks
Pain and function questionnaire measure. Scale for pain ranges from "Very severe" to "Had no pain". Scale for pain interference ranges from " Very much" to "not at all". Scale of functionality ranges from "unable to do" to "without any difficulty" in regards to a range of specified activities. Change is reported in mean foot reported pain score Screening/Baseline visit to 4 Week visit. Questions related to pain include items 1-5, total pain score possible is 25; higher scores indicate less pain reported.
Four Weeks
Change in Foot Pain From Screening/Baseline Visit to 4 Week Visit as Reported on the Manchester Foot and Ankle Index.
Time Frame: Four Weeks

Pain and function questionnaire assessment. Three responses to a variety of pain and specified activities raging from "On most/every day(s)" which is scored as 2 to "none of the time" which is scored as 0. Summation is made on Functional (0-20 with 20 being the lowest functioning), Personal appearance (0-4 with 4 being the worst), pain (0-10 with 10 being the worst), work/leisure (0-100 with 100 being the worst impact on work/leisure).

Change in mean foot pain as reported on the Manchester Foot and Ankle Index from Screening/Baseline visit to 4 Week visit. Pain subscale is questions 13-17, range is 0-10 total points, lower scores indicate less pain.
Four Weeks
Change in Foot Pain From Screening/Baseline Visit to 4 Week Visit as Reported on the Mayo Clinical Scoring System Questionnaire.
Time Frame: Four Weeks

Pain and function questionnaire. Pain scale from 0 (worst) to 50 (no pain). Activity limitations, orthotic requirements, antalgic gait, neuropathy and plantar heel tenderness are all graded 10 (best) to 10 (worst). Overall summation is excellent (90-100), good (80-89), fair (70-79), poor (<70).

Change in mean foot pain score on Mayo Clinical Scoring System Questionnaire from Screening/Baseline Visit to 4 Week Visit. Pain scale is the first question, 50 total points, with higher scores meaning less pain.
Four Weeks
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.
Time Frame: Four Weeks

This survey assesses pain (40 points possible, comprises pain subtotal), function (50 points possible, comprises function subtotal; which includes activity limitations, maximum walking distance, difficulty with walking surfaces, gait abnormality, sagittal motion, hindfoot motion and ankle/hindfoot stability, and alignment (10 possible points, comprises alignment subtotal). A total score is calculated out of 100, with higher scores indicating greater impairment. There are also calculated subtotals specific to pain, function and alignment.

Change in mean foot pain score on AOFAS from Screening/Baseline Visit to 4 Week Visit. Pain scale is 40 total points, with higher scores meaning less pain.
Four Weeks
Device Durability
Time Frame: Four weeks.
Documentation of the number of participants who wore a single device for first 4 weeks of the participant's study participation.
Four weeks.
Participant Compliance With Device
Time Frame: Four Weeks
Documentation of the number of participants who did not wear a single device for the full 4 weeks of the participant's study participation.
Four Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants' Reported Satisfaction and/or Difficulties With the Device
Time Frame: Four Weeks
As measured by subject self report, using a device satisfaction measure questionnaire. Questions are answered yes/no in all cases except comfort (1-10 with 10 being the most comfortable), and ease of use (1-10 with 10 being most easy to use).
Four Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeffrey A. Gusenoff, MD

Investigators

  • Principal Investigator: Jeffrey Gusenoff, MD, Professor of Plastic Surgery, Director of the Foot Fat Grafting Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2020

Primary Completion (Actual)

October 20, 2021

Study Completion (Actual)

October 20, 2021

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

May 4, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20010059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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