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
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 20, 2021
• Est. primary completion date: October 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Aged 18 years or older and able to provide informed consent

2. 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

3. Willing and able to comply with follow up examinations

Exclusion Criteria:

1. Concurrent injury to the lower extremity that would effect gait

2. Open foot ulcerations, fractures, or diagnosis of osteomyelitis of the feet

3. Surgical foot intervention in the last 6 months

4. Diagnosis of pregnancy or the intent of the participant to become pregnant during participation in this study

5. Neuropathy

6. 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.)

Related Conditions & MeSH terms

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

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)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

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