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Offloading Device for Post Surgical Foot Procedures

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ClinicalTrials.gov Identifier: NCT03873207
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Jeffrey A. Gusenoff, MD, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE March 8, 2019
First Posted Date  ICMJE March 13, 2019
Last Update Posted Date September 26, 2019
Estimated Study Start Date  ICMJE December 2019
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
  • Ultrasonography [ Time Frame: at screening ]
    Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound
  • Ultrasonography [ Time Frame: 1 month post-op ]
    Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound
  • Ultrasonography [ Time Frame: 2 months post-op ]
    Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound
  • Ultrasonography [ Time Frame: 6 months post-op ]
    Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound
  • American Orthopedic Foot and Ankle Society questionnaire (AOFAS). [ Time Frame: at screening ]
    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
  • American Orthopedic Foot and Ankle Society questionnaire (AOFAS). [ Time Frame: 1 month post-op ]
    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
  • American Orthopedic Foot and Ankle Society questionnaire (AOFAS). [ Time Frame: 2 months post-op ]
    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
  • American Orthopedic Foot and Ankle Society questionnaire (AOFAS). [ Time Frame: 6 months post-op ]
    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
  • Pittsburgh Foot Survey [ Time Frame: at screening ]
    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
  • Pittsburgh Foot Survey [ Time Frame: 1 month post-op ]
    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
  • Pittsburgh Foot Survey [ Time Frame: 2 months post-op ]
    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
  • Pittsburgh Foot Survey [ Time Frame: 6 months post-op ]
    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
  • Manchester Foot and Ankle Disability Index [ Time Frame: at screening ]
    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).
  • Manchester Foot and Ankle Disability Index [ Time Frame: 1 month post-op ]
    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).
  • Manchester Foot and Ankle Disability Index [ Time Frame: 2 months post-op ]
    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).
  • Manchester Foot and Ankle Disability Index [ Time Frame: 6 months post-op ]
    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).
  • Mayo Clinical Scoring System questionnaire (MAYO) [ Time Frame: at screening ]
    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)
  • Mayo Clinical Scoring System questionnaire (MAYO) [ Time Frame: 1 month post-op ]
    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)
  • Mayo Clinical Scoring System questionnaire (MAYO) [ Time Frame: 2 months post-op ]
    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)
  • Mayo Clinical Scoring System questionnaire (MAYO) [ Time Frame: 6 months post-op ]
    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)
  • Foot and Ankle Ability Measure (FAAM) questionnaire [ Time Frame: at screening ]
    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.
  • Foot and Ankle Ability Measure (FAAM) questionnaire [ Time Frame: 1 month post-op ]
    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.
  • Foot and Ankle Ability Measure (FAAM) questionnaire [ Time Frame: 2 months post-op ]
    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.
  • Foot and Ankle Ability Measure (FAAM) questionnaire [ Time Frame: 6 months post-op ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
  • Ultrasonography [ Time Frame: at screening ]
    Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound
  • Ultrasonography [ Time Frame: 1 month post-op ]
    Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound
  • Ultrasonography [ Time Frame: 2 months post-op ]
    Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound
  • Ultrasonography [ Time Frame: 6 months post-op ]
    Tissue thickness (skin, soft tissue, and plantar fascia thickness) as assessed by ultrasound
  • Pain and function questionnaire measure [ Time Frame: at screening ]
    American Orthopaedic Foot and Ankle Society questionnaire (AOFAS)
  • Pain and function questionnaire measure [ Time Frame: 1 month post-op ]
    American Orthopaedic Foot and Ankle Society questionnaire (AOFAS)
  • Pain and function questionnaire measure [ Time Frame: 2 months post-op ]
    American Orthopaedic Foot and Ankle Society questionnaire (AOFAS)
  • Pain and function questionnaire measure [ Time Frame: 6 months post-op ]
    American Orthopaedic Foot and Ankle Society questionnaire (AOFAS)
  • Pain and function questionnaire measure [ Time Frame: at screening ]
    Pittsburgh Foot Survey
  • Pain and function questionnaire measure [ Time Frame: 1 month post-op ]
    Pittsburgh Foot Survey
  • Pain and function questionnaire measure [ Time Frame: 2 months post-op ]
    Pittsburgh Foot Survey
  • Pain and function questionnaire measure [ Time Frame: 6 months post-op ]
    Pittsburgh Foot Survey
  • Pain and function questionnaire measure [ Time Frame: at screening ]
    Manchester Foot and Ankle Disability Index
  • Pain and function questionnaire measure [ Time Frame: 1 month post-op ]
    Manchester Foot and Ankle Disability Index
  • Pain and function questionnaire measure [ Time Frame: 2 months post-op ]
    Manchester Foot and Ankle Disability Index
  • Pain and function questionnaire measure [ Time Frame: 6 months post-op ]
    Manchester Foot and Ankle Disability Index
  • Pain and function questionnaire measure [ Time Frame: at screening ]
    Mayo Clinical Scoring System questionnaire (MAYO)
  • Pain and function questionnaire measure [ Time Frame: 1 month post-op ]
    Mayo Clinical Scoring System questionnaire (MAYO)
  • Pain and function questionnaire measure [ Time Frame: 2 months post-op ]
    Mayo Clinical Scoring System questionnaire (MAYO)
  • Pain and function questionnaire measure [ Time Frame: 6 months post-op ]
    Mayo Clinical Scoring System questionnaire (MAYO)
  • Pain and function questionnaire measure [ Time Frame: at screening ]
    Foot and Ankle Ability Measure (FAAM) questionnaire
  • Pain and function questionnaire measure [ Time Frame: 1 month post-op ]
    Foot and Ankle Ability Measure (FAAM) questionnaire
  • Pain and function questionnaire measure [ Time Frame: 2 months post-op ]
    Foot and Ankle Ability Measure (FAAM) questionnaire
  • Pain and function questionnaire measure [ Time Frame: 6 months post-op ]
    Foot and Ankle Ability Measure (FAAM) questionnaire
Change History Complete list of historical versions of study NCT03873207 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
  • Offload Device Survey [ Time Frame: at screening ]
    Device satisfaction measure questionnaire. Questions are answered yes/no in all cases except comfort (0-10 with 10 being the most comfortable), ease of use (0-10 with 10 being most easy to use) and how many hours per night a patient needed to wear a night splint (0-8).
  • Offload Device Survey [ Time Frame: 2 weeks post-op ]
    Device satisfaction measure questionnaire. Questions are answered yes/no in all cases except comfort (0-10 with 10 being the most comfortable), ease of use (0-10 with 10 being most easy to use) and how many hours per night a patient needed to wear a night splint (0-8).
  • Offload Device Survey [ Time Frame: 1 month post-op ]
    Device satisfaction measure questionnaire. Questions are answered yes/no in all cases except comfort (0-10 with 10 being the most comfortable), ease of use (0-10 with 10 being most easy to use) and how many hours per night a patient needed to wear a night splint (0-8).
  • Offload Device Survey [ Time Frame: 2 months post-op ]
    Device satisfaction measure questionnaire. Questions are answered yes/no in all cases except comfort (0-10 with 10 being the most comfortable), ease of use (0-10 with 10 being most easy to use) and how many hours per night a patient needed to wear a night splint (0-8).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
  • Device satisfaction measure questionnaire [ Time Frame: at screening ]
    Satisfaction with using the device, difficulties with the use of the device assessed using the Offload Device Survey
  • Device satisfaction measure questionnaire [ Time Frame: 2 weeks post-op ]
    Satisfaction with using the device, difficulties with the use of the device assessed using the Offload Device Survey
  • Device satisfaction measure questionnaire [ Time Frame: 1 month post-op ]
    Satisfaction with using the device, difficulties with the use of the device assessed using the Offload Device Survey
  • Device satisfaction measure questionnaire [ Time Frame: 2 months post-op ]
    Satisfaction with using the device, difficulties with the use of the device assessed using the Offload Device Survey
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Offloading Device for Post Surgical Foot Procedures
Official Title  ICMJE 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

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.

Detailed Description

Subjects will complete the following screening research procedures:

  1. Baseline reported outcome measures (PROMs) questionnaires and surveys that will take approximately 25 minutes to complete:

    • Foot and Ankle Ability Measure (FAAM) questionnaire to assess subject ADL and function ability
    • Mayo Clinical Scoring System questionnaire (MAYO) to assess subject pain, activity and function
    • American Orthopaedic Foot and Ankle Society questionnaire (AOFAS) to assess subject pain and function
    • Manchester Foot and Ankle Disability Index to assess subject foot pain/discomfort
    • Pittsburgh Foot Survey to assess subject pain, activity, life satisfaction/quality of life
    • Offload Device Survey to assess the ease and comfort of the offload device
  2. Foot ultrasounds will be performed to assess and measure baseline thickness of the plantar fascia, forefoot, or heel.
  3. 2D Photographs of both feet will be performed for a visual baseline assessment skin and soft tissue thickness.

If the clinical fat graft procedure occurs on a day different from the screening visit, the following research activities will be completed at Visit 2 if the subject continues to remain interested and eligible for study participation:

  1. Collection of subject's vital signs (Temp, HR, Resp., BP), medication profile, allergies, weight, BMI calculation and adverse event collection and reporting.
  2. Medical and surgical history collection review - the Investigator will confirm that the subject's medical status has not changed since last seen and the subject continues to satisfy eligibility criteria for study intervention.
  3. Performance of a limited physical and foot exam by PI and /or Co-investigator MD
  4. Women of childbearing potential will receive a urine pregnancy dip test with results documented to study chart.
  5. Diary cards with instruction to start entry on the diary card 24 hours after the fat grafting surgery to continue through Post-operative Visit 4 (Month 1) and be placed to study chart. The subject will be instructed to document self-assessment of the following events pertaining to the surgical site: Pain, Bruising, Redness of the skin, Itching, Swelling, Bleeding, Other (any concerns/issues not listed). The subject will be instructed to identify on the diary card the location, date and day of each documented event. Unresolved events at Visit 4 will be carried over for documentation to the adverse event log.
  6. 2D Photographs of both feet
  7. 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
prospective, randomized two cohort (device or SOC) pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Plantar Fascitis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Intervention
    Pedal fat grafting followed by PopSole™ offloading device
    Intervention: Device: PopSole™ offloading device
  • Standard of care
    Pedal fat grafting followed by standard post-operative care with padding of the insoles
    Intervention: Device: padded insole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 11, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Aged 18 years or older and able to provide informed consent
  2. 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
  3. Willing and able to comply with follow up examinations, including ultrasounds

Exclusion Criteria:

  1. Concurrent injury to the lower extremity that would effect gait
  2. Open foot ulcerations, fractures, or diagnosis of osteomyelitis of the feet
  3. Surgical foot intervention in the last 6 months
  4. Diagnosis of pregnancy or the intent of the participant to become pregnant during participation in this study
  5. 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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jack E Brooker, MB BChir 4123837808 jeb331@pitt.edu
Contact: Matthew T Bottegal, BA 4126412007 mab62@pitt.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03873207
Other Study ID Numbers  ICMJE PRO18070586
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jeffrey A. Gusenoff, MD, University of Pittsburgh
Study Sponsor  ICMJE Jeffrey A. Gusenoff, MD
Collaborators  ICMJE University of Pittsburgh
Investigators  ICMJE
Principal Investigator: Jeffrey A Gusenoff, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP