Offloading Device for Post Surgical Foot Procedures
Public ClinicalTrials.gov record NCT03873207. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03873207
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2022
- Primary completion
- Sep 30, 2022
- Completion
- Sep 30, 2022
- Last update posted
- Jan 30, 2024
2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UPMC Magee Women's Hospital | Pittsburgh | Pennsylvania | 15213 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03873207, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 30, 2024 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03873207 live on ClinicalTrials.gov.