Volumetric Analysis in Autologous Fat Grafting to the Foot

Pedal Fat Pad Atrophy Clinical Trial

Official title:

Volumetric Analysis in Autologous Fat Grafting to the Foot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02638532
• Other study ID #: PRO15090106
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: September 30, 2019

Study information

• Verified date: December 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 30, 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Pedal Fat Pad Atrophy

Intervention

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.

Locations

Country	Name	City	State
United States	UPMC Department of Plastic Surgery	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 6 months post-procedure
Secondary	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.	Baseline, 1 month, 2 months and 6 months post-procedure
Secondary	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.	Baseline, 1 month, 2 months and 6 months post-procedure
Secondary	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.	Fat grafting procedure, 6 months
Secondary	Manchester Foot Disability Index for pain	Pain is assessed through the completion of a questionnaire that is scored.	baseline, 1 month, 2 month and 6 month post procedure.
Secondary	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.	baseline, 1 mont, 2 month, and 6 month post procedure.