CompletedNot Applicable

Volumetric Analysis in Autologous Fat Grafting to the Foot

United States17 participantsStarted 2016-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.).

Exclusion criteria

✕. 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.

What they're measuring

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.

Timeframe: Baseline and 6 months post-procedure

Trial details

NCT IDNCT02638532

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-01

View on ClinicalTrials.gov More Pedal Fat Pad Atrophy trials