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NCT04378270 Clinical Trial

Validation of a Novel Foot Offloading Device

Heel Pain Syndrome Clinical Trial

— PopSole2  

Official title:
Validation of a Novel Foot Offloading Device

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04378270
Other study ID # STUDY20010059
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 26, 2020
Est. completion date October 20, 2021

Study information
Verified date January 2024
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

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Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States UPMC Aesthetic Plastic Surgery Center Pittsburgh Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Jeffrey A. Gusenoff, MD

Country where clinical trial is conducted

United States, 

References & Publications (19)

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Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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.
Primary 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 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
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