Offloading Device for Post Surgical Foot Procedures
Keywords
Abstract
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.
Dates
| Last Verified: | 06/30/2020 |
| First Submitted: | 03/07/2019 |
| Estimated Enrollment Submitted: | 03/10/2019 |
| First Posted: | 03/12/2019 |
| Last Update Submitted: | 07/09/2020 |
| Last Update Posted: | 07/13/2020 |
| Actual Study Start Date: | 11/30/2020 |
| Estimated Primary Completion Date: | 12/31/2021 |
| Estimated Study Completion Date: | 01/31/2022 |
Condition or disease
Intervention/treatment
Device: Intervention
Device: Standard of care
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Intervention Pedal fat grafting followed by PopSole™ offloading device | Device: Intervention 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. |
| Other: Standard of care Pedal fat grafting followed by standard post-operative care with padding of the insoles | Device: Standard of care the control arm will be provided with standard padded insole to wear inside footwear |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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.) |
Outcome
Primary Outcome Measures
1. Ultrasonography [at screening]
2. Ultrasonography [1 month post-op]
3. Ultrasonography [2 months post-op]
4. Ultrasonography [6 months post-op]
5. American Orthopedic Foot and Ankle Society questionnaire (AOFAS). [at screening]
6. American Orthopedic Foot and Ankle Society questionnaire (AOFAS). [1 month post-op]
7. American Orthopedic Foot and Ankle Society questionnaire (AOFAS). [2 months post-op]
8. American Orthopedic Foot and Ankle Society questionnaire (AOFAS). [6 months post-op]
9. Pittsburgh Foot Survey [at screening]
10. Pittsburgh Foot Survey [1 month post-op]
11. Pittsburgh Foot Survey [2 months post-op]
12. Pittsburgh Foot Survey [6 months post-op]
13. Manchester Foot and Ankle Disability Index [at screening]
14. Manchester Foot and Ankle Disability Index [1 month post-op]
15. Manchester Foot and Ankle Disability Index [2 months post-op]
16. Manchester Foot and Ankle Disability Index [6 months post-op]
17. Mayo Clinical Scoring System questionnaire (MAYO) [at screening]
18. Mayo Clinical Scoring System questionnaire (MAYO) [1 month post-op]
19. Mayo Clinical Scoring System questionnaire (MAYO) [2 months post-op]
20. Mayo Clinical Scoring System questionnaire (MAYO) [6 months post-op]
21. Foot and Ankle Ability Measure (FAAM) questionnaire [at screening]
22. Foot and Ankle Ability Measure (FAAM) questionnaire [1 month post-op]
23. Foot and Ankle Ability Measure (FAAM) questionnaire [2 months post-op]
24. Foot and Ankle Ability Measure (FAAM) questionnaire [6 months post-op]
Secondary Outcome Measures
1. Offload Device Survey [at screening]
2. Offload Device Survey [2 weeks post-op]
3. Offload Device Survey [1 month post-op]
4. Offload Device Survey [2 months post-op]
