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Diagnostic Modeling for Pedal Fat Pad Atrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679651
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey A. Gusenoff, MD, University of Pittsburgh

Tracking Information
First Submitted Date February 6, 2016
First Posted Date February 10, 2016
Last Update Posted Date July 14, 2020
Study Start Date January 2016
Actual Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 6, 2016)
  • Plantar fat pad thickness [ Time Frame: Screening ]
    Fat pad thickness measured via ultrasound
  • Plantar foot pressure [ Time Frame: Screening ]
    Assessed by optical pedobarograph
  • Pain score [ Time Frame: Screening ]
    Assessed by patient completed Manchester foot pain and disability index
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnostic Modeling for Pedal Fat Pad Atrophy
Official Title Diagnostic Modeling for Pedal Fat Pad Atrophy
Brief Summary The investigators hypothesize that there is a difference in plantar tissue thickness, plantar pressure, and pain score in patients diagnosed with plantar fat pad atrophy compared to healthy, foot-type matched controls. Results will be measured objectively using ultrasound for tissue thickness, optical pedobarograph for plantar pressure, and Manchester foot pain and disability index (MFPDI) for pain score. Furthermore, investigators predict that these results will help establish criteria for fad pad atrophy diagnosis in the clinic as well as determine which patients would receive greatest benefit from fat grafting to the foot.
Detailed Description

Human feet must bear the entire weight of the body. Feet have fat pads on their plantar surface that act as shock absorbers between the skin and bone. However, repetitive mechanical stress throughout a person's lifetime leads to gradual atrophy of these fat pads. In addition to this age-related degeneration, fat pad atrophy can be caused by other mechanisms such as abnormal foot mechanics, steroid use, and collagen vascular disease. Regardless of the cause, many patients with plantar fat pad atrophy experience considerable pain and loss of function.

Previous studies have negatively correlated plantar soft tissue thickness with plantar pressure, with the loss of plantar fat being a fundamental mechanism associated with pressure-related foot disorders. Increased pressure from fat pad atrophy is commonly managed with padded socks, insoles, and shoe modification. However, these extrinsic strategies are totally dependent on patient compliance, and devices must be replaced as soon as they begin to break down. Another treatment option includes silicone injections into the plantar aspect of the foot. In one study, patients receiving silicone treatment experienced increased plantar tissue thickness and decreased plantar pressure, but these cushioning properties decreased over time and the need for additional booster injections was ultimately suggested. Furthermore, silicone has been known to migrate away from the injection site and has been found in the inguinal lymph nodes of patients.

A different strategy that is gaining momentum is autologous fat grafting to the foot. Taking a patient's own tissue, often from the abdomen or thigh, and transplanting it to areas of plantar fat pad atrophy may reduce pressure in a more natural and permanent manner. Only one study to date has been published on autologous fat grafting to the foot, but the patients were receiving concurrent surgical procedures with their fat grafting and the results were reported subjectively by the patients.

In this study, the investigators hypothesize that there is a difference in plantar tissue thickness, plantar pressure, and pain score in patients diagnosed with plantar fat pad atrophy compared to healthy, foot-type matched controls. Results will be measured objectively using ultrasound for tissue thickness, optical pedobarograph for plantar pressure, and Manchester foot pain and disability index (MFPDI) for pain score. Furthermore, the investigators predict that these results will help establish criteria for fad pad atrophy diagnosis in the clinic as well as determine which patients would receive greatest benefit from fat grafting to the foot.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 30 healthy, age matched adults with normal foot fat pads to compare to 30 patients in the fat pad atrophy group from our other IRB approved clinical trials.
Condition
  • Fat Pad Atrophy
  • Pain
Intervention
  • Other: Ultrasound of the foot
    An ultrasound will be used to determine the thickness of the fat pad
  • Other: Pedobarograph Measurements
    This non-invasive device measures the force and pressure of the foot while standing and walking.
  • Other: Manchester Foot Pain and Disability Index
    This is a patient completed questionnaire that assesses level of function from the past month specific to foot pain.
Study Groups/Cohorts
  • Control group
    Healthy Adults without foot pain
    Interventions:
    • Other: Ultrasound of the foot
    • Other: Pedobarograph Measurements
    • Other: Manchester Foot Pain and Disability Index
  • DIsease group
    Adults diagnosed with fat pat atrophy and report symptoms of foot pain and have participated in clinical trial to treat fat pad atrophy.
    Interventions:
    • Other: Ultrasound of the foot
    • Other: Pedobarograph Measurements
    • Other: Manchester Foot Pain and Disability Index
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 22, 2017)
20
Original Estimated Enrollment
 (submitted: February 6, 2016)
50
Actual Study Completion Date January 2020
Actual Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Aged 18 years or older
  2. Patients without foot pain at the plantar surface of the foot near the head of the metatarsals
  3. 6 months post any surgical intervention to the foot
  4. Subjects must be determined by the PI or a Co-Investigator to not suffer from pedal pad atrophy

Exclusion Criteria:

  1. Age less than 18 years
  2. Inability to provide informed consent
  3. Feet with open ulcerations or osteomyelitis
  4. Diabetics: Type I and II
  5. Active infection anywhere in the body
  6. Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment
  7. Pregnancy
  8. Tobacco use: Last use within 1 year per patient report
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02679651
Other Study ID Numbers PRO15060610
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jeffrey A. Gusenoff, MD, University of Pittsburgh
Study Sponsor University of Pittsburgh
Collaborators Not Provided
Investigators
Principal Investigator: Jeffrey A Gusenoff, MD University of Pittsburgh Department of Plastic Surgery
Principal Investigator: Connor Davenport, BS University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date July 2020