Volumetric Analysis in Autologous Fat Grafting to the Foot
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|ClinicalTrials.gov Identifier: NCT02638532|
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : December 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pedal Fat Pad Atrophy||Procedure: Foot Fat Pad Grafting||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Volumetric Analysis in Autologous Fat Grafting to the Foot|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||September 30, 2019|
Foot Fat Pad Grafting
All subject who enter into the study will undergo the fat pad grafting procedure to either the Heel or Forefoot based on the discretion of the PI, Co-investigator and the study subject.
Procedure: Foot Fat Pad Grafting
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.
- 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. [ Time Frame: Baseline and 6 months post-procedure ]Comparative analysis of the scans will be done to note fat re-distribution and bone quality pre and post procedure.
- Ultrasound to measure tissue thickness of foot [ Time Frame: Baseline, 1 month, 2 months and 6 months post-procedure ]Tissue thickness will be measured in MM. They will utilized to ascertain changes from pre procedure to 6 months post-procedure.
- Pedobarograph to measure foot pressure and force while standing and walking [ Time Frame: Baseline, 1 month, 2 months and 6 months post-procedure ]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.
- Adipose stem cell counts [ Time Frame: Fat grafting procedure, 6 months ]excess fat from the procedure will be sent for stem cell analysis and used to corelate to retention of fat over time.
- Manchester Foot Disability Index for pain [ Time Frame: baseline, 1 month, 2 month and 6 month post procedure. ]Pain is assessed through the completion of a questionnaire that is scored.
- Foot and Ankle Ability Measure for physical activity [ Time Frame: baseline, 1 mont, 2 month, and 6 month post procedure. ]Activity level is assessed by subject rating different activities on the difficulty to complete the activities. The questionnaire is then scored.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638532
|United States, Pennsylvania|
|UPMC Department of Plastic Surgery|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Jeffery A Gusenoff, MD||University of Pittsburgh|