Treating Pain at Amputation Sites with Fat Grafting

STUDY BASICS

Did you have a total or partial limb amputation due to an accident or injury? Does your prosthesis cause pain and/or discomfort? If so, you may be able to participate in a research study to find out if fat grafting (removing fat from one area of the body and injecting it into another) can reduce limb pain and help the prosthesis fit better. Compensation provided.

STUDY PURPOSE

When a person suffers the loss of a body part (amputation) due to accident or injury, an artificial body part called a prosthesis is often used to help the person to return to their normal activities and functioning. However, many patients with amputations experience pain when wearing a prosthesis because they do not have enough padding over their bony structures and nerves. The purpose of this study is to find out if a procedure called fat grafting can increase padding and reduce pain at the site of amputation, and help the prosthesis fit better. Fat grafting is a minimally-invasive procedure in which a person’s own fat is removed from one area and injected into another. Fat grafting is commonly used as a cosmetic and reconstructive procedure, but is considered to be experimental when used in people who have had amputations due to accident or injury.

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 18 and up
• Suffered an injury that resulted in the loss or partial loss of a limb
• Experiencing pain at the amputation site that limits the fitting and use of the prosthesis
• At least 3 months post-injury or post-surgery

WHAT PARTICIPANTS CAN EXPECT

Participants in this study lasts 26-28 months and includes 10-11 visits and 3 phone interviews. Your initial screening visit includes a review of your medical and surgical history, a physical exam, a blood draw, a urine pregnancy test for women, and other assessments. If you qualify for the study, you will be randomly assigned (like a flip of a coin) to one of two groups. One group of people will have standard fat grafting procedure; the other group will have a concentrated fat grafting procedure. You will be followed over 24 months post operatively to measure outcomes. During the fat grafting procedure visits and follow-up visits, you will have multiple tests and assessments.