NCT03873207

Offloading Device for Post Surgical Foot Procedures

Withdrawn NA Last updated 31 January 2024

What this trial tests

NA trial testing PopSole™ offloading device in Plantar Fascitis. Withdrawn.

Timeline

1 October 2022

Primary endpoint
1 October 2022

1 October 2022

Quick facts

Lead sponsor	Jeffrey A. Gusenoff, MD
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	1 October 2022
Primary completion	1 October 2022
Estimated completion	1 October 2022
Sites	1 location across United States

Drugs / interventions tested

• PopSole™ offloading device
• padded insole

Conditions studied

• Plantar Fascitis — all drugs for Plantar Fascitis →
• Fat Pad Syndrome — all drugs for Fat Pad Syndrome →

Sponsor

Jeffrey A. Gusenoff, MD

Who can join

18 and older, any sex, with Plantar Fascitis or Fat Pad Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.