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OpenTrials
Completed

NCT Number: NCT02679651

Diagnostic Modeling for Pedal Fat Pad Atrophy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UPMC Department of Plastic Surgury

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age less than 18 years
  • Inability to provide informed consent
  • Feet with open ulcerations or osteomyelitis
  • Diabetics: Type I and II
  • Active infection anywhere in the body
  • Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment
  • Pregnancy
  • Tobacco use: Last use within 1 year per patient report

Treatment and study plan

Ultrasound of the foot

Other

An ultrasound will be used to determine the thickness of the fat pad

Pedobarograph Measurements

Other

This non-invasive device measures the force and pressure of the foot while standing and walking.

Manchester Foot Pain and Disability Index

Other

This is a patient completed questionnaire that assesses level of function from the past month specific to foot pain.

Primary outcomes

  1. Plantar fat pad thickness

    Time frame: Screening

    Fat pad thickness measured via ultrasound

  2. Plantar foot pressure

    Time frame: Screening

    Assessed by optical pedobarograph

  3. Pain score

    Time frame: Screening

    Assessed by patient completed Manchester foot pain and disability index

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Feb 10, 2016
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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