Offloading Device for Post Surgical Foot Procedures

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 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.

Conditions

• Plantar Fascitis
• Fat Pad Syndrome

Interventions

DEVICE

PopSole™ offloading device

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.

DEVICE

padded insole

the control arm will be provided with standard padded insole to wear inside footwear

Sponsors & Collaborators

• University of Pittsburgh

  collaborator OTHER

• Jeffrey A. Gusenoff, MD

  lead OTHER

Principal Investigators

• Jeffrey A Gusenoff, MD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-01

Primary Completion

2022-10-01

Completion

2022-10-01

FDA Device

Yes

Countries

• United States

Study Locations