Clinical trial NCT03873207: Offloading Device for Post Surgical Foot Procedures
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Plantar Fascitis
Fat Pad Syndrome
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2019-03-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized two cohort (device or SOC) pilot study
Primary purpose: TREATMENT

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:

1. 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
2. Foot ultrasounds will be performed to assess and measure baseline thickness of the plantar fascia, forefoot, or heel.
3. 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:

1. Collection of subject's vital signs (Temp, HR, Resp., BP), medication profile, allergies, weight, BMI calculation and adverse event collection and reporting.
2. 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.
3. Performance of a limited physical and foot exam by PI and /or Co-investigator MD
4. Women of childbearing potential will receive a urine pregnancy dip test with results documented to study chart.
5. 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.
6. 2D Photographs of both feet
7. 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.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or older and able to provide informed consent
2. 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
3. Willing and able to comply with follow up examinations, including ultrasounds

Exclusion Criteria:

1. Concurrent injury to the lower extremity that would effect gait
2. Open foot ulcerations, fractures, or diagnosis of osteomyelitis of the feet
3. Surgical foot intervention in the last 6 months
4. Diagnosis of pregnancy or the intent of the participant to become pregnant during participation in this study
5. 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.)

Primary outcomes:
measure: Ultrasonography
timeFrame: at screening
measure: Ultrasonography
timeFrame: 1 month post-op
measure: Ultrasonography
timeFrame: 2 months post-op
measure: Ultrasonography
timeFrame: 6 months post-op
measure: American Orthopedic Foot and Ankle Society questionnaire (AOFAS).
timeFrame: at screening
measure: American Orthopedic Foot and Ankle Society questionnaire (AOFAS).
timeFrame: 1 month post-op
measure: American Orthopedic Foot and Ankle Society questionnaire (AOFAS).
timeFrame: 2 months post-op
measure: American Orthopedic Foot and Ankle Society questionnaire (AOFAS).
timeFrame: 6 months post-op
measure: Pittsburgh Foot Survey
timeFrame: at screening
measure: Pittsburgh Foot Survey
timeFrame: 1 month post-op
measure: Pittsburgh Foot Survey
timeFrame: 2 months post-op
measure: Pittsburgh Foot Survey
timeFrame: 6 months post-op
measure: Manchester Foot and Ankle Disability Index
timeFrame: at screening
measure: Manchester Foot and Ankle Disability Index
timeFrame: 1 month post-op
measure: Manchester Foot and Ankle Disability Index
timeFrame: 2 months post-op
measure: Manchester Foot and Ankle Disability Index
timeFrame: 6 months post-op
measure: Mayo Clinical Scoring System questionnaire (MAYO)
timeFrame: at screening
measure: Mayo Clinical Scoring System questionnaire (MAYO)
timeFrame: 1 month post-op
measure: Mayo Clinical Scoring System questionnaire (MAYO)
timeFrame: 2 months post-op
measure: Mayo Clinical Scoring System questionnaire (MAYO)
timeFrame: 6 months post-op
measure: Foot and Ankle Ability Measure (FAAM) questionnaire
timeFrame: at screening
measure: Foot and Ankle Ability Measure (FAAM) questionnaire
timeFrame: 1 month post-op
measure: Foot and Ankle Ability Measure (FAAM) questionnaire
timeFrame: 2 months post-op
measure: Foot and Ankle Ability Measure (FAAM) questionnaire
timeFrame: 6 months post-op
Secondary outcomes:
measure: Offload Device Survey
timeFrame: at screening
measure: Offload Device Survey
timeFrame: 2 weeks post-op
measure: Offload Device Survey
timeFrame: 1 month post-op
measure: Offload Device Survey
timeFrame: 2 months post-op
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Magee Women's Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jeffrey A Gusenoff, MD
role: PRINCIPAL_INVESTIGATOR
References: