Plantar FascitisNCT03873207
Offloading Device for Post Surgical Foot Procedures
A study testing PopSole™ offloading device and padded insole in people with Plantar Fascitis and Fat Pad Syndrome, run by Jeffrey A. Gusenoff, MD at 1 site in United States.
Trial summary
Study goals are to determine if a novel post-surgical foot offloading device can reduce post-operative pain and expedite the return to daily activity following fat grafting. Investigators will perform a prospective, randomized study utilizing PopSole™, a novel fully customizable post-operative shoe insert, to aid in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fascitis, Fat Pad Syndrome
- What is being tested?
- PopSole™ offloading device and padded insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 scheduled to undergo a standard of care treatment with fat grafting for 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, including ultrasounds
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
- 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 Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Prospective Randomized Trial Comparing PopSole™ Offloading Device to Standard of Care Methods for the Reduction of Pain and Expedited Recovery in Patients Post Fat Graft Procedure
Study goals are to determine if a novel post-surgical foot offloading device can reduce post-operative pain and expedite the return to daily activity following fat grafting. Investigators will perform a prospective, randomized study utilizing PopSole™, a novel fully customizable post-operative shoe insert, to aid in the recovery of patients post-surgical fat graft injections for pain and limited activity due to foot disorders (ie. fat pad atrophy of the forefoot, heel, or for chronic plantar fasciitis).
Standard of care fat grafting is often used in plastic surgery for cosmetic or reconstructive reasons. Foot fat grafting, though not considered part of this research trial, is routinely offered in the UPMC Aesthetic Plastic Surgery center as a cosmetic surgery option; however, treatment modality options following the completion of a foot fat grafting procedure to protect the fat grafts and reduce weight bearing on the fresh fat grafts are limited. Current standard of care options including crutches, scooters, bulky post-operative shoes (ie. Darco shoes [Darco Intl. Huntington WV.]), and the addition of padding to insoles or orthotics that attempt to offload the treated area. Most of these devices are flat and provide poor anatomical support, leading to compensatory gait issues which can lead to further problems and pain in the knees, hips, and back. The most common complication with post-operative foot gear is non-compliance: patients do not wear it.
The investigators have devised a novel foot offloading device (PopSole™) which will allow for customization of the area where the fat has been injected into the foot, as well as allow for customizable arch support and elevation of the metatarsals. By randomizing patients to recovery with standard methods versus this new device, the investigators are hopeful for earlier patient ambulation and return to work with decreased pain.
Read the detailed description
Subjects will complete the following screening research procedures:
- Baseline reported outcome measures (PROMs) questionnaires and surveys that will take approximately 25 minutes to complete:
- Foot and Ankle Ability Measure (FAAM) questionnaire to assess subject ADL and function ability
- Mayo Clinical Scoring System questionnaire (MAYO) to assess subject pain, activity and function
- American Orthopaedic Foot and Ankle Society questionnaire (AOFAS) to assess subject pain and function
- Manchester Foot and Ankle Disability Index to assess subject foot pain/discomfort
- Pittsburgh Foot Survey to assess subject pain, activity, life satisfaction/quality of life
- Offload Device Survey to assess the ease and comfort of the offload device
- Foot ultrasounds will be performed to assess and measure baseline thickness of the plantar fascia, forefoot, or heel.
- 2D Photographs of both feet will be performed for a visual baseline assessment skin and soft tissue thickness.
If the clinical fat graft procedure occurs on a day different from the screening visit, the following research activities will be completed at Visit 2 if the subject continues to remain interested and eligible for study participation:
- Collection of subject's vital signs (Temp, HR, Resp., BP), medication profile, allergies, weight, BMI calculation and adverse event collection and reporting.
- Medical and surgical history collection review - the Investigator will confirm that the subject's medical status has not changed since last seen and the subject continues to satisfy eligibility criteria for study intervention.
- Performance of a limited physical and foot exam by PI and /or Co-investigator MD
- Women of childbearing potential will receive a urine pregnancy dip test with results documented to study chart.
- Diary cards with instruction to start entry on the diary card 24 hours after the fat grafting surgery to continue through Post-operative Visit 4 (Month 1) and be placed to study chart. The subject will be instructed to document self-assessment of the following events pertaining to the surgical site: Pain, Bruising, Redness of the skin, Itching, Swelling, Bleeding, Other (any concerns/issues not listed). The subject will be instructed to identify on the diary card the location, date and day of each documented event. Unresolved events at Visit 4 will be carried over for documentation to the adverse event log.
- 2D Photographs of both feet
- Offload Device Distribution to remain in use at all times during ambulation and activity instruction to stay off of feet as much as possible for 3 days, then limit ambulation to 10 minutes per hour for 4 weeks and no sports, kicking, running or exercise for 4 weeks. Devices will be provided for both feet to maintain symmetry and gait stability between the two feet.
- Conditions
- Plantar Fascitis, Fat Pad Syndrome
- Being tested
- PopSole™ offloading device, padded insole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PopSole™ offloading deviceDevice
Offload Device Distribution to remain in use at all times during ambulation and activity instruction to stay off of feet as much as possible for 3 days, then limit ambulation to 10 minutes per hour for 4 weeks and no sports, kicking, running or exercise for 4 weeks. Devices will be provided for both feet to maintain symmetry and gait stability between the two feet.
padded insoleDevice
the control arm will be provided with standard padded insole to wear inside footwear
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Pedal fat grafting followed by PopSole™ offloading device Receives: Device: PopSole™ offloading device |
| Standard of care | Other | Pedal fat grafting followed by standard post-operative care with padding of the insoles Receives: Device: padded insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonography
Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound
Measured: at screening
Ultrasonography
Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound
Measured: 1 month post-op
Ultrasonography
Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound
Measured: 2 months post-op
Ultrasonography
Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound
Measured: 6 months post-op
American Orthopedic Foot and Ankle Society questionnaire (AOFAS).
This survey assesses gait (no abnormality to severe abnormality), ankle motion restriction (no restriction to severe restriction), difficulty with waling on uneven surfaces (no difficulty to severe difficulty) and alignment (good to poor). There is no overall summation of results
Measured: at screening
American Orthopedic Foot and Ankle Society questionnaire (AOFAS).
This survey assesses gait (no abnormality to severe abnormality), ankle motion restriction (no restriction to severe restriction), difficulty with waling on uneven surfaces (no difficulty to severe difficulty) and alignment (good to poor). There is no overall summation of results
Measured: 1 month post-op
American Orthopedic Foot and Ankle Society questionnaire (AOFAS).
This survey assesses gait (no abnormality to severe abnormality), ankle motion restriction (no restriction to severe restriction), difficulty with waling on uneven surfaces (no difficulty to severe difficulty) and alignment (good to poor). There is no overall summation of results
Measured: 2 months post-op
American Orthopedic Foot and Ankle Society questionnaire (AOFAS).
This survey assesses gait (no abnormality to severe abnormality), ankle motion restriction (no restriction to severe restriction), difficulty with waling on uneven surfaces (no difficulty to severe difficulty) and alignment (good to poor). There is no overall summation of results
Measured: 6 months post-op
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. There is no overall summation of results
Measured: at screening
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. There is no overall summation of results
Measured: 1 month post-op
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. There is no overall summation of results
Measured: 2 months post-op
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. There is no overall summation of results
Measured: 6 months post-op
Manchester Foot and Ankle Disability 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).
Measured: at screening
Manchester Foot and Ankle Disability 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).
Measured: 1 month post-op
Manchester Foot and Ankle Disability 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).
Measured: 2 months post-op
Manchester Foot and Ankle Disability 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).
Measured: 6 months post-op
Mayo Clinical Scoring System questionnaire (MAYO)
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)
Measured: at screening
Mayo Clinical Scoring System questionnaire (MAYO)
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)
Measured: 1 month post-op
Mayo Clinical Scoring System questionnaire (MAYO)
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)
Measured: 2 months post-op
Mayo Clinical Scoring System questionnaire (MAYO)
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)
Measured: 6 months post-op
Foot and Ankle Ability Measure (FAAM) questionnaire
Mobility and functionality questionnaire. Scale ranges from "Unable to do" to "no difficulty at all" in response to questions on mobility. There is no overall summation of results.
Measured: at screening
Foot and Ankle Ability Measure (FAAM) questionnaire
Mobility and functionality questionnaire. Scale ranges from "Unable to do" to "no difficulty at all" in response to questions on mobility. There is no overall summation of results.
Measured: 1 month post-op
Foot and Ankle Ability Measure (FAAM) questionnaire
Mobility and functionality questionnaire. Scale ranges from "Unable to do" to "no difficulty at all" in response to questions on mobility. There is no overall summation of results.
Measured: 2 months post-op
Foot and Ankle Ability Measure (FAAM) questionnaire
Mobility and functionality questionnaire. Scale ranges from "Unable to do" to "no difficulty at all" in response to questions on mobility. There is no overall summation of results.
Measured: 6 months post-op
Secondary outcomes (4)
Offload Device Survey
Device satisfaction measure questionnaire. Questions are answered yes/no in all cases except comfort (0-10 with 10 being the most comfortable), ease of use (0-10 with 10 being most easy to use) and how many hours per night a patient needed to wear a night splint (0-8).
Measured: at screening
Offload Device Survey
Device satisfaction measure questionnaire. Questions are answered yes/no in all cases except comfort (0-10 with 10 being the most comfortable), ease of use (0-10 with 10 being most easy to use) and how many hours per night a patient needed to wear a night splint (0-8).
Measured: 2 weeks post-op
Offload Device Survey
Device satisfaction measure questionnaire. Questions are answered yes/no in all cases except comfort (0-10 with 10 being the most comfortable), ease of use (0-10 with 10 being most easy to use) and how many hours per night a patient needed to wear a night splint (0-8).
Measured: 1 month post-op
Offload Device Survey
Device satisfaction measure questionnaire. Questions are answered yes/no in all cases except comfort (0-10 with 10 being the most comfortable), ease of use (0-10 with 10 being most easy to use) and how many hours per night a patient needed to wear a night splint (0-8).
Measured: 2 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start1 Oct 2022
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Why it stopped: This study (NCT03873207) was closed with the University of Pittsburgh's HRPO office (STUDY19080348) in January 2021, prior to enrolling any subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized two cohort (device or SOC) pilot study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeffrey A. Gusenoff, MD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Sponsor-investigator, Jeffrey A. Gusenoff, MD, University of Pittsburgh
- Investigators
- Jeffrey A Gusenoff, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873207
- Sponsor's protocol ID
- STUDY19080348
- Status last verified
- Jan 2024
- First submitted
- 8 Mar 2019
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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
- A Prospective Randomized Trial Comparing PopSole™ Offloading Device to Standard of Care Methods for the Reduction of Pain and Expedited Recovery in Patients Post Fat Graft Procedure
- ClinicalTrials.gov ID
- NCT03873207
- Acronym / sponsor ID
- STUDY19080348
- Conditions
- Plantar Fascitis, Fat Pad Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study (NCT03873207) was closed with the University of Pittsburgh's HRPO office (STUDY19080348) in January 2021, prior to enrolling any subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jeffrey A. Gusenoff, MDUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study goals are to determine if a novel post-surgical foot offloading device can reduce post-operative pain and expedite the return to daily activity following fat grafting. Investigators will perform a prospective, randomized study utilizing PopSole™, a novel fully customizable post-operative shoe insert, to aid in the recovery of patients post-surgical fat graft injections for pain and limited activity due to foot disorders (ie. fat pad atrophy of the forefoot, heel, or for chronic plantar fasciitis).
Standard of care fat grafting is often used in plastic surgery for cosmetic or reconstructive reasons. Foot fat grafting, though not considered part of this research trial, is routinely offered in the UPMC Aesthetic Plastic Surgery center as a cosmetic surgery option; however, treatment modality options following the completion of a foot fat grafting procedure to protect the fat grafts and reduce weight bearing on the fresh fat grafts are limited. Current standard of care options including crutches, scooters, bulky post-operative shoes (ie. Darco shoes [Darco Intl. Huntington WV.]), and the addition of padding to insoles or orthotics that attempt to offload the treated area. Most of these devices are flat and provide poor anatomical support, leading to compensatory gait issues which can lead to further problems and pain in the knees, hips, and back. The most common complication with post-operative foot gear is non-compliance: patients do not wear it.
The investigators have devised a novel foot offloading device (PopSole™) which will allow for customization of the area where the fat has been injected into the foot, as well as allow for customizable arch support and elevation of the metatarsals. By randomizing patients to recovery with standard methods versus this new device, the investigators are hopeful for earlier patient ambulation and return to work with decreased pain.
Detailed description
Subjects will complete the following screening research procedures:
- Baseline reported outcome measures (PROMs) questionnaires and surveys that will take approximately 25 minutes to complete:
- Foot and Ankle Ability Measure (FAAM) questionnaire to assess subject ADL and function ability
- Mayo Clinical Scoring System questionnaire (MAYO) to assess subject pain, activity and function
- American Orthopaedic Foot and Ankle Society questionnaire (AOFAS) to assess subject pain and function
- Manchester Foot and Ankle Disability Index to assess subject foot pain/discomfort
- Pittsburgh Foot Survey to assess subject pain, activity, life satisfaction/quality of life
- Offload Device Survey to assess the ease and comfort of the offload device
- Foot ultrasounds will be performed to assess and measure baseline thickness of the plantar fascia, forefoot, or heel.
- 2D Photographs of both feet will be performed for a visual baseline assessment skin and soft tissue thickness.
If the clinical fat graft procedure occurs on a day different from the screening visit, the following research activities will be completed at Visit 2 if the subject continues to remain interested and eligible for study participation:
- Collection of subject's vital signs (Temp, HR, Resp., BP), medication profile, allergies, weight, BMI calculation and adverse event collection and reporting.
- Medical and surgical history collection review - the Investigator will confirm that the subject's medical status has not changed since last seen and the subject continues to satisfy eligibility criteria for study intervention.
- Performance of a limited physical and foot exam by PI and /or Co-investigator MD
- Women of childbearing potential will receive a urine pregnancy dip test with results documented to study chart.
- Diary cards with instruction to start entry on the diary card 24 hours after the fat grafting surgery to continue through Post-operative Visit 4 (Month 1) and be placed to study chart. The subject will be instructed to document self-assessment of the following events pertaining to the surgical site: Pain, Bruising, Redness of the skin, Itching, Swelling, Bleeding, Other (any concerns/issues not listed). The subject will be instructed to identify on the diary card the location, date and day of each documented event. Unresolved events at Visit 4 will be carried over for documentation to the adverse event log.
- 2D Photographs of both feet
- Offload Device Distribution to remain in use at all times during ambulation and activity instruction to stay off of feet as much as possible for 3 days, then limit ambulation to 10 minutes per hour for 4 weeks and no sports, kicking, running or exercise for 4 weeks. Devices will be provided for both feet to maintain symmetry and gait stability between the two feet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, randomized two cohort (device or SOC) pilot study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: PopSole™ offloading devicePedal fat grafting followed by PopSole™ offloading device |
| Standard of care | Other | Device: padded insolePedal fat grafting followed by standard post-operative care with padding of the insoles |
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 scheduled to undergo a standard of care treatment with fat grafting for 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, including ultrasounds
Key exclusion criteria (5 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
- 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.)
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 deviceOffload Device Distribution to remain in use at all times during ambulation and activity instruction to stay off of feet as much as possible for 3 days, then limit ambulation to 10 minutes per hour for 4 weeks and no sports, kicking, running or exercise for 4 weeks. Devices will be provided for both feet to maintain symmetry and gait stability between the two feet. | Device | Intervention |
| padded insolethe control arm will be provided with standard padded insole to wear inside footwear | Device | Standard of care |
Primary outcome
Ultrasonography
Time frame: at screening
Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound
Ultrasonography
Time frame: 1 month post-op
Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound
Ultrasonography
Time frame: 2 months post-op
Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound
Ultrasonography
Time frame: 6 months post-op
Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound
American Orthopedic Foot and Ankle Society questionnaire (AOFAS).
Time frame: at screening
This survey assesses gait (no abnormality to severe abnormality), ankle motion restriction (no restriction to severe restriction), difficulty with waling on uneven surfaces (no difficulty to severe difficulty) and alignment (good to poor). There is no overall summation of results
American Orthopedic Foot and Ankle Society questionnaire (AOFAS).
Time frame: 1 month post-op
This survey assesses gait (no abnormality to severe abnormality), ankle motion restriction (no restriction to severe restriction), difficulty with waling on uneven surfaces (no difficulty to severe difficulty) and alignment (good to poor). There is no overall summation of results
American Orthopedic Foot and Ankle Society questionnaire (AOFAS).
Time frame: 2 months post-op
This survey assesses gait (no abnormality to severe abnormality), ankle motion restriction (no restriction to severe restriction), difficulty with waling on uneven surfaces (no difficulty to severe difficulty) and alignment (good to poor). There is no overall summation of results
American Orthopedic Foot and Ankle Society questionnaire (AOFAS).
Time frame: 6 months post-op
This survey assesses gait (no abnormality to severe abnormality), ankle motion restriction (no restriction to severe restriction), difficulty with waling on uneven surfaces (no difficulty to severe difficulty) and alignment (good to poor). There is no overall summation of results
Pittsburgh Foot Survey
Time frame: at screening
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. There is no overall summation of results
Pittsburgh Foot Survey
Time frame: 1 month post-op
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. There is no overall summation of results
Pittsburgh Foot Survey
Time frame: 2 months post-op
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. There is no overall summation of results
Pittsburgh Foot Survey
Time frame: 6 months post-op
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. There is no overall summation of results
Manchester Foot and Ankle Disability Index
Time frame: at screening
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).
Manchester Foot and Ankle Disability Index
Time frame: 1 month post-op
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).
Manchester Foot and Ankle Disability Index
Time frame: 2 months post-op
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).
Manchester Foot and Ankle Disability Index
Time frame: 6 months post-op
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).
Mayo Clinical Scoring System questionnaire (MAYO)
Time frame: at screening
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)
Mayo Clinical Scoring System questionnaire (MAYO)
Time frame: 1 month post-op
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)
Mayo Clinical Scoring System questionnaire (MAYO)
Time frame: 2 months post-op
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)
Mayo Clinical Scoring System questionnaire (MAYO)
Time frame: 6 months post-op
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)
Foot and Ankle Ability Measure (FAAM) questionnaire
Time frame: at screening
Mobility and functionality questionnaire. Scale ranges from "Unable to do" to "no difficulty at all" in response to questions on mobility. There is no overall summation of results.
Foot and Ankle Ability Measure (FAAM) questionnaire
Time frame: 1 month post-op
Mobility and functionality questionnaire. Scale ranges from "Unable to do" to "no difficulty at all" in response to questions on mobility. There is no overall summation of results.
Foot and Ankle Ability Measure (FAAM) questionnaire
Time frame: 2 months post-op
Mobility and functionality questionnaire. Scale ranges from "Unable to do" to "no difficulty at all" in response to questions on mobility. There is no overall summation of results.
Foot and Ankle Ability Measure (FAAM) questionnaire
Time frame: 6 months post-op
Mobility and functionality questionnaire. Scale ranges from "Unable to do" to "no difficulty at all" in response to questions on mobility. There is no overall summation of results.
4 secondary outcomes
Offload Device Survey
Time frame: at screening
Offload Device Survey
Time frame: 2 weeks post-op
Offload Device Survey
Time frame: 1 month post-op
Offload Device Survey
Time frame: 2 months post-op
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- 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 A Gusenoff, MD principal investigator
University of Pittsburgh
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 and padded insole in people with Plantar Fascitis and Fat Pad 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 5 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: withdrawn, 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Ultrasonography (time frame: at screening). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.