Diagnostic Modeling for Pedal Fat Pad Atrophy

July 10, 2020 updated by: Jeffrey A. Gusenoff, MD, University of Pittsburgh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Department of Plastic Surgury

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
Healthy Adults without foot pain
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plantar fat pad thickness
Time Frame: Screening
Fat pad thickness measured via ultrasound
Screening
Plantar foot pressure
Time Frame: Screening
Assessed by optical pedobarograph
Screening
Pain score
Time Frame: Screening
Assessed by patient completed Manchester foot pain and disability index
Screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Jeffrey A Gusenoff, MD, University of Pittsburgh Department of Plastic Surgery
  • Principal Investigator: Connor Davenport, BS, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

February 6, 2016

First Submitted That Met QC Criteria

February 6, 2016

First Posted (Estimate)

February 10, 2016

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 10, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO15060610

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Ultrasound of the foot

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe