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Completed

NCT Number: NCT04378270

Validation of a Novel Foot Offloading Device

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.

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Key information

Conditions

Plantar Fasciitis, Chronic Fasciitis Fasciitis, Plantar Fat Pad Syndrome Foot Diseases Heel Pain Syndrome Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Aesthetic Plastic Surgery Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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:

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

Subjects will be asked to complete:

  • 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
  • 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.
  • 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

  • Collection of vital signs, medication profile, weight, and BMI calculation
  • Limited physical exam with a foot exam
  • Adverse Event Reporting
  • Collection and distribution of feet diary cards
  • 2D Photographs of both feet
  • Foot Assessment Questionnaires
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older and able to provide informed consent
  • 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
  • Willing and able to comply with follow up examinations

Exclusion criteria

  • Concurrent injury to the lower extremity that would effect gait
  • Open foot ulcerations, fractures, or diagnosis of osteomyelitis of the feet
  • Surgical foot intervention in the last 6 months
  • Diagnosis of pregnancy or the intent of the participant to become pregnant during participation in this study
  • Neuropathy
  • 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.)

Treatment and study plan

PopSole™ Offloading Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Jeffrey A. Gusenoff, MD

Other

Registry information

Acronym: PopSole2

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 7, 2020
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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