Not provided
Not provided
Not provided
Not provided
Not provided
This study (NCT03873207) was closed with the University of Pittsburgh's HRPO office (STUDY19080348) in January 2021, prior to enrolling any subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
Not provided
Not provided
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.
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 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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Pedal fat grafting followed by PopSole™ offloading device |
|
| Standard of care | Other | Pedal fat grafting followed by standard post-operative care with padding of the insoles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PopSole™ offloading device | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasonography | Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound | at screening |
| Ultrasonography | Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound | 1 month post-op |
| Ultrasonography | Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound | 2 months post-op |
| Ultrasonography | Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound | 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 | 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 | 1 month post-op |
| American Orthopedic Foot and Ankle Society questionnaire (AOFAS). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at screening |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey A Gusenoff, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Magee Women's Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
prospective, randomized two cohort (device or SOC) pilot study
Not provided
Not provided
Not provided
Not provided
|
| padded insole | Device | the control arm will be provided with standard padded insole to wear inside footwear |
|
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 |
| 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 | 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 | 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 | 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 | 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 | 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). | 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). | 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). | 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). | 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) | 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) | 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) | 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) | 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. | 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. | 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. | 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. | 6 months 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). |
| 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). | 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). | 2 months post-op |