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Volumetric Analysis in Autologous Fat Grafting to the Foot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638532
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey A. Gusenoff, MD, University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pedal Fat Pad Atrophy Procedure: Foot Fat Pad Grafting Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 18 years or older, basically healthy and able to provide informed consent.
  2. Patients with forefoot or rearfoot pain overlying the bone with fat pad atrophy.
  3. At least 6 months post any surgical intervention to the foot.
  4. Willing and able to comply with follow up examinations, including ultrasounds, MRI, and pedobarographic studies.
  5. Diabetics: Type I and II with a HgA1C < or = 7.
  6. Have tried and failed at least one form of conservative management (i.e. orthotics, padding, etc.).

Exclusion Criteria:

  1. Age less than 18 years.
  2. Inability to provide informed consent
  3. Feet with open ulcerations or osteomyelitis.
  4. Diabetics: Type I and II iwth a HgAIC > 7.
  5. Active infection anywhere in the body.
  6. Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment.
  7. Known coagulopathy.
  8. Systemic disease that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient.
  9. Pregnancy.
  10. Subjects with a diagnosis of Schizophrenia or Bipolar Disorder due to the inability to comply with study instructions, due in part to comorbidities (Subjects who are found to be stable on medication and receive psychiatric clearance could be eligible for study participation per the Physician's discretion).
  11. Tobacco use: Last use within 1 year per patient report.
  12. Patients with heart pacemakers, aneurysm clips, ear implants, IUD, shrapnel or metallic fragments in or on the body or eyes, neuro-stimulators, or other metal devices.

Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
UPMC Department of Plastic Surgery
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Jeffery A Gusenoff, MD University of Pittsburgh
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Responsible Party: Jeffrey A. Gusenoff, MD, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02638532    
Other Study ID Numbers: PRO15090106
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
Keywords provided by Jeffrey A. Gusenoff, MD, University of Pittsburgh:
Fat Pad
Fat Pad Atrophy
Foot
Feet
Heel
Forefoot
Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical