Volumetric Analysis in Autologous Fat Grafting to the Foot

Completed · Not applicable

Conditions studied: Pedal Fat Pad Atrophy

In brief

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.

Key facts

Study ID

NCT02638532

Run by

University of Pittsburgh

People needed

17

Starts

2016-01-01

Expected to finish

2019-09-30

Last updated by the study team

2019-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Age less than 18 years.
• Inability to provide informed consent
• Feet with open ulcerations or osteomyelitis.
• Diabetics: Type I and II iwth a HgAIC > 7.
• Active infection anywhere in the body.
• Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment.
• Known coagulopathy.
• Systemic disease that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient.
• Pregnancy.
• 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).
• Tobacco use: Last use within 1 year per patient report.
• 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.

Where it is running

• UPMC Department of Plastic Surgery — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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