Volumetric Analysis in Autologous Fat Grafting to the Foot

NCT02638532 | Completed

• 1 other identifier: PRO15090106
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Pedal Fat Pad Atrophy

Keywords

Fat Pad; Fat Pad Atrophy; Foot; Feet; Heel; Forefoot

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (5)

• Ultrasound to measure tissue thickness of foot

  Baseline, 1 month, 2 months and 6 months post-procedure

• Pedobarograph to measure foot pressure and force while standing and walking

  Baseline, 1 month, 2 months and 6 months post-procedure

• Adipose stem cell counts

  Fat grafting procedure, 6 months

• Manchester Foot Disability Index for pain

  baseline, 1 month, 2 month and 6 month post procedure.

• Foot and Ankle Ability Measure for physical activity

  baseline, 1 mont, 2 month, and 6 month post procedure.

Study Arms (1)

Foot Fat Pad Grafting

OTHER

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

Interventions

Foot Fat Pad Grafting PROCEDURE

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.

Foot Fat Pad Grafting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Department of Plastic Surgery

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

• Jeffery A Gusenoff, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 23, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: September 30, 2019
• Last Updated: December 6, 2019

Record last verified: 2019-12

Locations

US (1)