Offloading Device for Post Surgical Foot Procedures

Study Overview
=================
Brief 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 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.

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

Conditions
-----------------
Plantar Fascitis, Fat Pad Syndrome

Intervention / Treatment
-----------------
* Device: PopSole™ offloading device
* Device: padded insole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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.)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomized two cohort (device or SOC) pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Pedal fat grafting followed by PopSole™ offloading device | Device: PopSole™ offloading device<br>* 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.<br>|
| Other: Standard of care<br>Pedal fat grafting followed by standard post-operative care with padding of the insoles | Device: padded insole<br>* the control arm will be provided with standard padded insole to wear inside footwear<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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). | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |