Offloading Device for Post Surgical Foot Procedures

NCT03873207 | Withdrawn DMC FDA Device

• 1 other identifier: STUDY19080348
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (24)

• Ultrasonography

  Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound

  at screening

• Ultrasonography

  Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound

  1 month post-op

• Ultrasonography

  Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound

  2 months post-op

• Ultrasonography

  Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound

  6 months post-op

• American Orthopedic Foot and Ankle Society questionnaire (AOFAS).

  This survey assesses gait (no abnormality to severe abnormality), ankle motion restriction (no restriction to severe restriction), difficulty with waling on uneven surfaces (no difficulty to severe difficulty) and alignment (good to poor). There is no overall summation of results

  at screening

• American Orthopedic Foot and Ankle Society questionnaire (AOFAS).

  This survey assesses gait (no abnormality to severe abnormality), ankle motion restriction (no restriction to severe restriction), difficulty with waling on uneven surfaces (no difficulty to severe difficulty) and alignment (good to poor). There is no overall summation of results

  1 month post-op

• American Orthopedic Foot and Ankle Society questionnaire (AOFAS).

  This survey assesses gait (no abnormality to severe abnormality), ankle motion restriction (no restriction to severe restriction), difficulty with waling on uneven surfaces (no difficulty to severe difficulty) and alignment (good to poor). There is no overall summation of results

  2 months post-op

• American Orthopedic Foot and Ankle Society questionnaire (AOFAS).

  This survey assesses gait (no abnormality to severe abnormality), ankle motion restriction (no restriction to severe restriction), difficulty with waling on uneven surfaces (no difficulty to severe difficulty) and alignment (good to poor). There is no overall summation of results

  6 months post-op

• Pittsburgh Foot Survey

  Pain and function questionnaire measure. Scale for pain ranges from "Very severe" to "Had no pain". Scale for pain interference ranges from " Very much" to "not at all". Scale of functionality ranges from "unable to do" to "without any difficulty" in regards to a range of specified activities. There is no overall summation of results

  at screening

• Pittsburgh Foot Survey

  Pain and function questionnaire measure. Scale for pain ranges from "Very severe" to "Had no pain". Scale for pain interference ranges from " Very much" to "not at all". Scale of functionality ranges from "unable to do" to "without any difficulty" in regards to a range of specified activities. There is no overall summation of results

  1 month post-op

• Pittsburgh Foot Survey

  Pain and function questionnaire measure. Scale for pain ranges from "Very severe" to "Had no pain". Scale for pain interference ranges from " Very much" to "not at all". Scale of functionality ranges from "unable to do" to "without any difficulty" in regards to a range of specified activities. There is no overall summation of results

  2 months post-op

• Pittsburgh Foot Survey

  Pain and function questionnaire measure. Scale for pain ranges from "Very severe" to "Had no pain". Scale for pain interference ranges from " Very much" to "not at all". Scale of functionality ranges from "unable to do" to "without any difficulty" in regards to a range of specified activities. There is no overall summation of results

  6 months post-op

• Manchester Foot and Ankle Disability Index

  Pain and function questionnaire assessment. Three responses to a variety of pain and specified activities raging from "On most/every day(s)" which is scored as 2 to "none of the time" which is scored as 0. Summation is made on Functional (0-20 with 20 being the lowest functioning), Personal appearance (0-4 with 4 being the worst), pain (0-10 with 10 being the worst), work/leisure (0-100 with 100 being the worst impact on work/leisure).

  at screening

• Manchester Foot and Ankle Disability Index

  Pain and function questionnaire assessment. Three responses to a variety of pain and specified activities raging from "On most/every day(s)" which is scored as 2 to "none of the time" which is scored as 0. Summation is made on Functional (0-20 with 20 being the lowest functioning), Personal appearance (0-4 with 4 being the worst), pain (0-10 with 10 being the worst), work/leisure (0-100 with 100 being the worst impact on work/leisure).

  1 month post-op

• Manchester Foot and Ankle Disability Index

  Pain and function questionnaire assessment. Three responses to a variety of pain and specified activities raging from "On most/every day(s)" which is scored as 2 to "none of the time" which is scored as 0. Summation is made on Functional (0-20 with 20 being the lowest functioning), Personal appearance (0-4 with 4 being the worst), pain (0-10 with 10 being the worst), work/leisure (0-100 with 100 being the worst impact on work/leisure).

  2 months post-op

• Manchester Foot and Ankle Disability Index

  Pain and function questionnaire assessment. Three responses to a variety of pain and specified activities raging from "On most/every day(s)" which is scored as 2 to "none of the time" which is scored as 0. Summation is made on Functional (0-20 with 20 being the lowest functioning), Personal appearance (0-4 with 4 being the worst), pain (0-10 with 10 being the worst), work/leisure (0-100 with 100 being the worst impact on work/leisure).

  6 months post-op

• Mayo Clinical Scoring System questionnaire (MAYO)

  Pain and function questionnaire. Pain scale from 0 (worst) to 50 (no pain). Activity limitations, orthotic requirements, antalgic gait, neuropathy and plantar heel tenderness are all graded 10 (best) to 10 (worst). Overall summation is excellent (90-100), good (80-89), fair (70-79), poor (\<70)

  at screening

• Mayo Clinical Scoring System questionnaire (MAYO)

  Pain and function questionnaire. Pain scale from 0 (worst) to 50 (no pain). Activity limitations, orthotic requirements, antalgic gait, neuropathy and plantar heel tenderness are all graded 10 (best) to 10 (worst). Overall summation is excellent (90-100), good (80-89), fair (70-79), poor (\<70)

  1 month post-op

• Mayo Clinical Scoring System questionnaire (MAYO)

  Pain and function questionnaire. Pain scale from 0 (worst) to 50 (no pain). Activity limitations, orthotic requirements, antalgic gait, neuropathy and plantar heel tenderness are all graded 10 (best) to 10 (worst). Overall summation is excellent (90-100), good (80-89), fair (70-79), poor (\<70)

  2 months post-op

• Mayo Clinical Scoring System questionnaire (MAYO)

  Pain and function questionnaire. Pain scale from 0 (worst) to 50 (no pain). Activity limitations, orthotic requirements, antalgic gait, neuropathy and plantar heel tenderness are all graded 10 (best) to 10 (worst). Overall summation is excellent (90-100), good (80-89), fair (70-79), poor (\<70)

  6 months post-op

• Foot and Ankle Ability Measure (FAAM) questionnaire

  Mobility and functionality questionnaire. Scale ranges from "Unable to do" to "no difficulty at all" in response to questions on mobility. There is no overall summation of results.

  at screening

• Foot and Ankle Ability Measure (FAAM) questionnaire

  Mobility and functionality questionnaire. Scale ranges from "Unable to do" to "no difficulty at all" in response to questions on mobility. There is no overall summation of results.

  1 month post-op

• Foot and Ankle Ability Measure (FAAM) questionnaire

  Mobility and functionality questionnaire. Scale ranges from "Unable to do" to "no difficulty at all" in response to questions on mobility. There is no overall summation of results.

  2 months post-op

• Foot and Ankle Ability Measure (FAAM) questionnaire

  Mobility and functionality questionnaire. Scale ranges from "Unable to do" to "no difficulty at all" in response to questions on mobility. There is no overall summation of results.

  6 months post-op

Secondary Outcomes (4)

• Offload Device Survey

  at screening

• Offload Device Survey

  2 weeks post-op

• Offload Device Survey

  1 month post-op

• Offload Device Survey

  2 months post-op

Study Arms (2)

Intervention

EXPERIMENTAL

Pedal fat grafting followed by PopSole™ offloading device

Device: PopSole™ offloading device

Standard of care

OTHER

Pedal fat grafting followed by standard post-operative care with padding of the insoles

Device: padded insole

Interventions

PopSole™ offloading device 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.

Intervention

padded insole DEVICE

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

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Jeffrey A. Gusenoff, MD: lead
• University of Pittsburgh: collaborator

Study Sites (1)

UPMC Magee Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

• Jeffrey A Gusenoff, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Plastic Surgery, University of Pittsburgh School of Medicine, Co-Director, Life After Weight Loss Program, Director, Foot Fat Grafting Institute

Model Details: prospective, randomized two cohort (device or SOC) pilot study

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 13, 2019
• Study Start: October 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)