The specific aim of this outcomes study is to assess if the volume of fat that is injected into the foot is retained at 6 months, to determine the retention over time, and assess the quality of the bone before and after treatment. We will also correlate adipose stem cell characteristics to the fat retention over time.
The study goal is to utilize MRI to further understand changes that are occurring in the foot when autologous fat is used to treat plantar fat pad atrophy of the foot. The etiology of fat pad atrophy may be age-related, due to abnormal foot mechanics, obesity, steroid use, or collagen vascular disease. Displacement or atrophy of the fat pad can lead to osseous prominences in the foot that may be seen with painful skin lesions. Disease states, such as diabetes, may have loss of soft tissue integrity. Fat pad atrophy may result in significant pain or compensatory gait leading to callous formation or ulceration. In sensate patients, the pain can lead to emotional and physical pain, leading to productivity and financial losses. Fat grafting to the feet is as a cosmetic surgery option. Although fat grafting is used often in standard care plastic surgery, for cosmetic reasons, it is considered part of the research in this trial. What happens to the fat after injection has not been well studied. Approximately 50 adults who experience pain from fat pad atrophy, either of the fore foot or heel will have fat pad grafting. The study will utilize MRI before and at 6 months post-procedure to assess changes in the quality of the bone of the foot as well as the 3D morphology of the fat. Specifically, the investigators want to know how the fat redistributes around the bone. In addition, the Adipose Stem Cell Biology Laboratory will assess the stem cell characteristics of the fat used for autotransplantation. This study will help build new collaborative efforts between Foot and Ankle Specialists, Stem Cell Biologists, and Plastic Surgeons, combining expertise in foot biomechanics with reconstructive fat grafting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Fat tissue to be used for grafting is harvested (usually from abdomen or thighs) with a small liposuction cannula. The fat tissue is then sterilely centrifuged and allowed to decant before separating the fluid and oil layers from the fat tissue fraction. The aspirated fat is then loaded into 1cc syringes and injected into the plantar fat pad using specialized injection cannulas.
UPMC Department of Plastic Surgery
Pittsburgh, Pennsylvania, United States
Utilize MRI to determine the 3D volumetric changes in the soft tissue of the foot after fat grafting and the changes in bone quality after fat grafting.
Comparative analysis of the scans will be done to note fat re-distribution and bone quality pre and post procedure.
Time frame: Baseline and 6 months post-procedure
Ultrasound to measure tissue thickness of foot
Tissue thickness will be measured in MM. They will utilized to ascertain changes from pre procedure to 6 months post-procedure.
Time frame: Baseline, 1 month, 2 months and 6 months post-procedure
Pedobarograph to measure foot pressure and force while standing and walking
Foot pressure is measured in Kg/cm2 or psi. The pedobarograph provides imaging to show areas of distribution of pressure to the foot when subject stands and walks.
Time frame: Baseline, 1 month, 2 months and 6 months post-procedure
Adipose stem cell counts
excess fat from the procedure will be sent for stem cell analysis and used to corelate to retention of fat over time.
Time frame: Fat grafting procedure, 6 months
Manchester Foot Disability Index for pain
Pain is assessed through the completion of a questionnaire that is scored.
Time frame: baseline, 1 month, 2 month and 6 month post procedure.
Foot and Ankle Ability Measure for physical activity
Activity level is assessed by subject rating different activities on the difficulty to complete the activities. The questionnaire is then scored.
Time frame: baseline, 1 mont, 2 month, and 6 month post procedure.
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