Validation of a Novel Foot Offloading Device

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Validation of a Novel Foot Offloading Device

Conditions
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Plantar Fasciitis, Chronic, Heel Pain Syndrome, Fat Pad Syndrome

Intervention / Treatment
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* Device: PopSole™ Offloading Device


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PopSole™ offloading device<br>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<br>* 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.<br>|

What is the study measuring?
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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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 |