Validation of a Novel Foot Offloading Device

Not Applicable

Completed

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

Interventions: Device: PopSole™ Offloading Device

Registration Number: NCT04378270

Lead Sponsor: Jeffrey A. Gusenoff, MD

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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.)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PopSole™ offloading device	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.

Primary Outcome Measures

Name	Time	Method
Change in Foot Pain From Screening/Baseline Visit to 4 Week Visit as Reported on the Pittsburgh Foot Survey.	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.
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.	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.
Participant Compliance With Device	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.
Change in Foot Pain From Screening/Baseline Visit to 4 Week Visit as Reported on the Manchester Foot and Ankle Index.	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.
Device Durability	Four weeks.	Documentation of the number of participants who wore a single device for first 4 weeks of the participant's study participation.
Change in Foot Pain From Screening/Baseline Visit to 4 Week Visit as Reported on the Mayo Clinical Scoring System Questionnaire.	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.

Secondary Outcome Measures

Name	Time	Method
Participants' Reported Satisfaction and/or Difficulties With the Device	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).