Validation of a Novel Foot Offloading Device

NCT04378270 | Completed Results FDA Device

• 1 other identifier: STUDY20010059
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Participants' Reported Satisfaction and/or Difficulties With the Device

  Four Weeks

Study Arms (1)

PopSole™ offloading device

EXPERIMENTAL

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

Interventions

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.

PopSole™ offloading device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Jeffrey A. Gusenoff, MD: lead

Study Sites (1)

UPMC Aesthetic Plastic Surgery Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (19)

• Gusenoff JA, Mitchell RT, Jeong K, Wukich DK, Gusenoff BR. Autologous Fat Grafting for Pedal Fat Pad Atrophy: A Prospective Randomized Clinical Trial. Plast Reconstr Surg. 2016 Nov;138(5):1099-1108. doi: 10.1097/PRS.0000000000002667.

  PMID: 27391833 BACKGROUND

• Minteer DM, Gusenoff BR, Gusenoff JA. Fat Grafting for Pedal Fat Pad Atrophy in a 2-Year, Prospective, Randomized, Crossover, Single-Center Clinical Trial. Plast Reconstr Surg. 2018 Dec;142(6):862e-871e. doi: 10.1097/PRS.0000000000005006.

  PMID: 30204683 BACKGROUND

• Swinnen E, Kerckhofs E. Compliance of patients wearing an orthotic device or orthopedic shoes: A systematic review. J Bodyw Mov Ther. 2015 Oct;19(4):759-70. doi: 10.1016/j.jbmt.2015.06.008. Epub 2015 Jul 2.

  PMID: 26592234 BACKGROUND

• Jarl G. Methodological considerations of investigating adherence to using offloading devices among people with diabetes. Patient Prefer Adherence. 2018 Sep 12;12:1767-1775. doi: 10.2147/PPA.S175738. eCollection 2018.

  PMID: 30254428 BACKGROUND

• Waaijman R, Keukenkamp R, de Haart M, Polomski WP, Nollet F, Bus SA. Adherence to wearing prescription custom-made footwear in patients with diabetes at high risk for plantar foot ulceration. Diabetes Care. 2013 Jun;36(6):1613-8. doi: 10.2337/dc12-1330. Epub 2013 Jan 15.

  PMID: 23321218 BACKGROUND

• Polat G, Karademir G, Akalan E, Asik M, Erdil M. Patient compliance with touchdown weight bearing after microfracture treatment of talar osteochondral lesions. J Orthop Surg Res. 2017 Mar 20;12(1):46. doi: 10.1186/s13018-017-0548-5.

  PMID: 28320425 BACKGROUND

• Arts ML, de Haart M, Bus SA, Bakker JP, Hacking HG, Nollet F. Perceived usability and use of custom-made footwear in diabetic patients at high risk for foot ulceration. J Rehabil Med. 2014 Apr;46(4):357-62. doi: 10.2340/16501977-1272.

  PMID: 24356801 BACKGROUND

• Bus SA, van Deursen RW, Kanade RV, Wissink M, Manning EA, van Baal JG, Harding KG. Plantar pressure relief in the diabetic foot using forefoot offloading shoes. Gait Posture. 2009 Jun;29(4):618-22. doi: 10.1016/j.gaitpost.2009.01.003. Epub 2009 Feb 13.

  PMID: 19217785 BACKGROUND

• Wunnemann M, Klein D, Rosenbaum D. Effects of the Twin Shoe (Darco) to compensate height differences in normal gait. Gait Posture. 2011 Jan;33(1):61-5. doi: 10.1016/j.gaitpost.2010.09.025. Epub 2010 Oct 20.

  PMID: 20961763 BACKGROUND

• Myers KA, Long JT, Klein JP, Wertsch JJ, Janisse D, Harris GF. Biomechanical implications of the negative heel rocker sole shoe: gait kinematics and kinetics. Gait Posture. 2006 Nov;24(3):323-30. doi: 10.1016/j.gaitpost.2005.10.006. Epub 2005 Nov 21.

  PMID: 16300949 BACKGROUND

• Braun BJ, Veith NT, Rollmann M, Orth M, Fritz T, Herath SC, Holstein JH, Pohlemann T. Weight-bearing recommendations after operative fracture treatment-fact or fiction? Gait results with and feasibility of a dynamic, continuous pedobarography insole. Int Orthop. 2017 Aug;41(8):1507-1512. doi: 10.1007/s00264-017-3481-7. Epub 2017 Apr 19.

  PMID: 28421239 BACKGROUND

• Bus SA, Maas JC, Otterman NM. Lower-extremity dynamics of walking in neuropathic diabetic patients who wear a forefoot-offloading shoe. Clin Biomech (Bristol). 2017 Dec;50:21-26. doi: 10.1016/j.clinbiomech.2017.10.003. Epub 2017 Oct 2.

  PMID: 28985487 BACKGROUND

• Robinson C, Major MJ, Kuffel C, Hines K, Cole P. Orthotic management of the neuropathic foot: an interdisciplinary care perspective. Prosthet Orthot Int. 2015 Feb;39(1):73-81. doi: 10.1177/0309364614545422.

  PMID: 25614503 BACKGROUND

• Jarl G, Tranberg R. An innovative sealed shoe to off-load and heal diabetic forefoot ulcers - a feasibility study. Diabet Foot Ankle. 2017 Jul 25;8(1):1348178. doi: 10.1080/2000625X.2017.1348178. eCollection 2017.

  PMID: 28804593 BACKGROUND

• de Oliveira AL, Moore Z. Treatment of the diabetic foot by offloading: a systematic review. J Wound Care. 2015 Dec;24(12):560, 562-70. doi: 10.12968/jowc.2015.24.12.560.

  PMID: 26654736 BACKGROUND

• Bus SA. The Role of Pressure Offloading on Diabetic Foot Ulcer Healing and Prevention of Recurrence. Plast Reconstr Surg. 2016 Sep;138(3 Suppl):179S-187S. doi: 10.1097/PRS.0000000000002686.

  PMID: 27556758 BACKGROUND

• Janisse DJ, Janisse E. Shoe modification and the use of orthoses in the treatment of foot and ankle pathology. J Am Acad Orthop Surg. 2008 Mar;16(3):152-8. doi: 10.5435/00124635-200803000-00006.

  PMID: 18316713 BACKGROUND

• Farber SE, Minteer D, Gusenoff BR, Gusenoff JA. The Influence of Fat Grafting on Skin Quality in Cosmetic Foot Grafting: A Randomized, Cross-Over Clinical Trial. Aesthet Surg J. 2019 Mar 14;39(4):405-412. doi: 10.1093/asj/sjy168.

  PMID: 30007274 BACKGROUND

• Lubarsky R, Gusenoff B, Gusenoff JA. Prospective Cohort Validation Study of a Novel Foot Offloading Device. Plast Reconstr Surg Glob Open. 2021 Nov 24;9(11):e3950. doi: 10.1097/GOX.0000000000003950. eCollection 2021 Nov.

  PMID: 34840921 RESULT

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Results Point of Contact

• Title: Jeffrey Gusenoff, MD
• Organization: University of Pittsburgh

gusenoffja@upmc.edu

(412) 641-3960

Study Officials

• Jeffrey Gusenoff, MD

  Professor of Plastic Surgery, Director of the Foot Fat Grafting Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Plastic Surgery, & Director, Foot Fat Grafting Institute

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: August 26, 2020
• Primary Completion: October 20, 2021
• Study Completion: October 20, 2021
• Last Updated: January 31, 2024
• Results First Posted: October 12, 2022

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)