Plantar Fasciitis, ChronicPopSole2NCT04378270
Validation of a Novel Foot Offloading Device
A study testing PopSole™ Offloading Device in people with Plantar Fasciitis, Chronic and Heel Pain Syndrome, run by Jeffrey A. Gusenoff, MD at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis, Chronic, Heel Pain Syndrome, Fat Pad Syndrome
- What is being tested?
- PopSole™ Offloading Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2020to 20 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Aesthetic Plastic Surgery Center
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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:
- 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.
- Being tested
- PopSole™ Offloading Device
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PopSole™ Offloading DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PopSole™ Offloading Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Four Weeks
Secondary outcomes (1)
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).
Measured: Four Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start26 Aug 2020
- Primary completion20 Oct 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Plantar Fasciitis, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeffrey A. Gusenoff, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeffrey A. Gusenoff, MD, University of Pittsburgh
- Investigators
- Jeffrey Gusenoff, MD, Principal investigator, Professor of Plastic Surgery, Director of the Foot Fat Grafting Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378270
- Sponsor's protocol ID
- STUDY20010059
- Acronym
- PopSole2
- Status last verified
- Jan 2024
- First submitted
- 4 May 2020
- Last updated
- 31 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27391833Minteer 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.
PubMed 30204683Swinnen 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.
PubMed 26592234Jarl 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.
PubMed 30254428Waaijman 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.
PubMed 23321218Polat 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.
PubMed 28320425Arts 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.
PubMed 24356801Bus 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.
PubMed 19217785Wunnemann 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.
PubMed 20961763Myers 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.
PubMed 16300949Braun 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.
PubMed 28421239Bus 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.
PubMed 28985487Robinson 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.
PubMed 25614503Jarl 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.
PubMed 28804593de 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.
PubMed 26654736
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Novel Foot Offloading Device
- ClinicalTrials.gov ID
- NCT04378270
- Acronym / sponsor ID
- PopSole2 / STUDY20010059
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jeffrey A. Gusenoff, MDUniversity, hospital or other
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Posted 12 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PopSole™ offloading device | Experimental | Device: PopSole™ Offloading DeviceThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PopSole™ Offloading DeviceSpecifically, 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. | Device | PopSole™ offloading device |
Primary outcome
Change in Foot Pain From Screening/Baseline Visit to 4 Week Visit as Reported on the Pittsburgh Foot Survey.
Time frame: 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 Manchester Foot and Ankle Index.
Time frame: 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.
Change in Foot Pain From Screening/Baseline Visit to 4 Week Visit as Reported on the Mayo Clinical Scoring System Questionnaire.
Time frame: 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.
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.
Time frame: 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.
Device Durability
Time frame: Four weeks.
Documentation of the number of participants who wore a single device for first 4 weeks of the participant's study participation.
Participant Compliance With Device
Time frame: 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.
1 secondary outcome
Participants' Reported Satisfaction and/or Difficulties With the Device
Time frame: Four Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27391833Gusenoff 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.
- Background: PubMed 30204683Minteer 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.
- Background: PubMed 26592234Swinnen 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.
- Background: PubMed 30254428Jarl 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.
- Background: PubMed 23321218Waaijman 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.
- Background: PubMed 28320425Polat 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.
- Background: PubMed 24356801Arts 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.
- Background: PubMed 19217785Bus 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.
- Background: PubMed 20961763Wunnemann 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.
- Background: PubMed 16300949Myers 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.
- Background: PubMed 28421239Braun 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.
- Background: PubMed 28985487Bus 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Gusenoff, MD principal investigator
Professor of Plastic Surgery, Director of the Foot Fat Grafting Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PopSole™ Offloading Device in people with Plantar Fasciitis, Chronic and Heel Pain Syndrome, run by Jeffrey A. Gusenoff, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Foot Pain From Screening/Baseline Visit to 4 Week Visit as Reported on the Pittsburgh Foot Survey. (time frame: Four Weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04378270, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.