Fat Grafting for Pedal Fat Pad Atrophy
Fat Grafting for Pedal Fat Pad Atrophy
It is believed that the average person with an eighty year old life span will walk the
 distance of the world twice in their lifetime. The foot is comprised of a specialized fat pad
 to provide shock absorption and protection against breakdown. With all the walking humans do
 however, foot fat pad breakdown is inevitable. Trauma to the foot is compounded in the
 diabetic patients due to many reasons: loss of protective sensation secondary to neuropathy,
 reduced skin hydration, decreased soft tissue elasticity, elevated blood sugars and increased
 body weight to name a few. Increased foot pressure and decreased fat pad protection are the
 main contributing factors to callus formation, foot pain and ulcer formation.

 Fat grafting is a cosmetic and reconstructive procedure that is used sometimes to help
 improve one's soft tissue thickness, shape and integrity. Autologous fat transplantation is a
 procedure using a patient's own fat that is taken by a small liposuction tube, from areas
 with a substantial amount of fat ( i.e. abdomen or thighs) and then transferred into the fat
 atrophied (decreased or worn out) area (in this case, the foot).

 The investigators are performing this research in an effort to decrease foot pressure during
 activity and to increase the soft tissue thickness of the sole of the foot during one's
 lifetime. Ultimately this could help reduce foot pain, callus formation and even ulcer
 formation. The goal of this research is to see whether fat grafting will help decrease the
 prevalence of the aforementioned foot complications. The investigators hope that by using
 one's own fat tissue, he or she may have a longer duration of relief than by using other
 methods.

 This is a randomized, cross-over designed study. Randomized means that patients will be
 enrolled by chance (like the flip of a coin) to one of two groups for the first part of the
 study. Cross-over means that, after the first part of the study or at one year, patients will
 move into the opposite group. One group will receive the fat grafting procedure with one year
 follow up (year A pathway) and the other will receive standard of care treatment from the
 patient's primary podiatrist during the first year (year B pathway). After the first year,
 patients will switch to the opposite year pathway for the next 12 months. Participation in
 this study will last approximately 24-26 months.
The etiology of plantar fat pad atrophy may be age-related, due abnormal foot mechanics,
 steroid use, or collagen vascular disease. Displacement or atrophy of the fat pad can lead to
 osseous prominences in the forefoot that may be seen with painful skin lesions. Disease
 states, such as diabetes, may have loss of soft tissue integrity. Fat pad atrophy, regardless
 of the etiology, may result in significant pain, epidermal lesions, or metatarsalgia. In
 sensate patients, the pain can lead to emotional and physical pain, leading to productivity
 and financial losses.1

 It is well documented that plantar pressure is directly correlated with plantar tissue
 thickness, with the loss of plantar fat being a fundamental mechanism for pressure related
 foot disorders.2,3 Autologous fat grafting to areas of plantar fat pad atrophy may reduce
 plantar pressures, and thus serve as a treatment for metatarsalgia, corn and callus
 prevention, and possibly ulcer prevention in diabetics. Plastic surgeons, with significant
 skills in fat grafting, can make a significant contribution.

 Current treatment modalities for fat pad atrophy include silicone injections, fat injections,
 and other temporary fillers; however, no objective studies using autologous fat have been
 performed. Approximately 30 adults who experience pain from fat pad atrophy, will have the
 option to participate. Through a randomized, controlled, cross-over study, some patients will
 receive autologous fat grafting, while some will receive standard of care podiatric
 treatment, then cross-over to fat grafting treatment after a year. Through pedobarograph and
 ultrasound assessments, the focal pedal pressure and tissue thickness following treatment
 will be documented over two years.

 The investigators hypothesize that fat grafting for areas of increased pedal pressure will
 help decrease foot pressure during gait and increase soft tissue thickness on the foot pad,
 ultimately reducing pain. The investigators also hope to demonstrate that by using autologous
 fat with evidence-based fat transfer techniques, results may be durable. This pilot study
 will help build new collaborative efforts between Foot and Ankle Surgery, Podiatry and
 Plastic Surgery, combining expertise in foot biomechanics with reconstructive fat grafting.
Inclusion Criteria:

 -  Aged 18 years or older and able to provide informed consent

 -  Patients with foot pain at the plantar surface of the foot near the head of the
 metacarpals

 -  6 months post any surgical intervention to the foot

 -  Willing and able to comply with follow up examinations, including ultrasounds and
 pedobarographic studies

 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

 -  Known coagulopathy

 -  Systemic disease that would render the fat harvest and injection procedure, along with
 associated anesthesia, unsafe to the patient.

 -  Pregnancy

 -  Subjects with a diagnosis of Schizophrenia or Bipolar Disorder (Subjects who are found
 to be stable on medication and receive psychiatric clearance could be eligible for
 study participation per the Physician's discretion).

 -  Tobacco use: Last use within 1 year per patient report