Status:
WITHDRAWN
Offloading Device for Post Surgical Foot Procedures
Lead Sponsor:
Jeffrey A. Gusenoff, MD
Collaborating Sponsors:
University of Pittsburgh
Conditions:
Plantar Fascitis
Fat Pad Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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: *...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03873207
Start Date
October 1 2022
End Date
October 1 2022
Last Update
January 31 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UPMC Magee Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213