Pedal Fat Pad Atrophy Clinical Trial
Official title:
Autologous 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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02638532 -
Volumetric Analysis in Autologous Fat Grafting to the Foot
|
N/A |