Status:
COMPLETED
Validation of a Novel Foot Offloading Device
Lead Sponsor:
Jeffrey A. Gusenoff, MD
Conditions:
Plantar Fasciitis, Chronic
Heel Pain Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Pressure offloading is often considered the most crucial aspect in healing after a foot injury. The investigators have devised a novel foot offloading device (PopSole™) which will allow for customizat...
Detailed Description
All subjects will receive the PopSole™ offloading device at the screening/baseline visit, be asked to wear it for 4 weeks, and will be asked to return for an in-person evaluation at week 2 and a compl...
Eligibility Criteria
Inclusion
- Aged 18 years or older and able to provide informed consent
- Subjects with 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
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
- Neuropathy
- 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 :
August 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04378270
Start Date
August 26 2020
End Date
October 20 2021
Last Update
January 31 2024
Active Locations (1)
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1
UPMC Aesthetic Plastic Surgery Center
Pittsburgh, Pennsylvania, United States, 15213