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

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Atrophy
• Pedal Fat Pad Atrophy

• NCT number: NCT02638532
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Completion date: September 30, 2019