Offloading Device for Post Surgical Foot Procedures
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/17/2019 |
| Start Date: | April 2019 |
| End Date: | February 2020 |
| Contact: | Jack E Brooker, MB BChir |
| Email: | jeb331@pitt.edu |
| Phone: | 4123837808 |
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.
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:
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.
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.
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.)
We found this trial at
1
site
Pittsburgh, Pennsylvania 15213
Principal Investigator: Jeffrey A Gusenoff, MD
Phone: 412-383-7808
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