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
Details
Lead Sponsor:
University of Pittsburgh
Treatments:
Anesthetics Anesthetics, Local Epinephrine Epinephryl borate Lidocaine Racepinephrine