Fat Grafting for Pedal Fat Pad Atrophy

• Status: Active, not recruiting
• Trial end date: 0000-00-00
• Target enrollment: 30
• Participant gender: Both

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Treatments: Anesthetics; Anesthetics, Local; Epinephrine; Epinephryl borate; Lidocaine; Racepinephrine
• Last Updated: 2016-10-20

Criteria

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