Study Tests Dermal Filler for Pain Due to Fat Pad Loss

A Chicago podiatrist has announced a pilot study to test a purportedly permanent, injectable dermal filler for treating foot pain due to fat-pad loss in the plantar metatarsal area. Mary Olszewski, DPM, American Board of Podiatric Orthopedic & Primary Podiatric Medicine, will evaluate the effects of ArteFill on pain and activity levels in fat-pad-loss patients who report foot pain and for whom foot pads, orthopedic shoes, orthotics, and/or other injectable dermal fillers have proven ineffective.

Artefill, produced by Artes Medical, of San Diego, California, combines approximately 20 percent polymethyl methacrylate (PMMA, also known as Plexiglas) microspheres, 80 percent bovine collagen gel, and a small amount of lidocaine, saline, and a phosphate buffer. It is the first injectable dermal filler containing PMMA to be approved by the U.S. Food and Drug Agency (FDA), and was approved in 2006 for a cosmetic use--filling nasolabial folds. It has been approved for use in Canada since 1991. According to a June 2003 article published in the journal Dermatalogic Surgery and authored by Gottfried Lemperle, MD, PhD, inventor of Artefill, the microspheres "stimulate fibroblasts to encapsulate each [microsphere]... [The bovine] collagen is merely a carrier substance that prevents the microspheres from agglomerating during tissue ingrowth. The 20 volume percent of microspheres in Artefill provides the scaffold for the 80 percent volume of connective tissue deposition, a complete replacement of the injected collagen." The recipient's connective-tissue regrowth around the microspheres is the cause of Artefill's claimed non-migration, and PMMA is not absorbed or known to degrade in the human body. The FDA's Summary of Safety and Effectiveness Data for Artefill states that adverse events recorded for Artefill occur at a rate similar to other injectable dermal fillers. They include "persistent swelling or redness, lumpiness at injection site more than one month after injection, blurred vision, flu-like symptoms, abscess, granuloma or enlargement of the implant, and alopecia areata."

According to Olszewski, ten participants will be enrolled from her own practice in the second half of 2008. ArteFill will be injected sub-dermally in the entire metatarsal area of one foot, leaving the contralateral foot as a control. According to Olszewski, participants are likely to be able to "walk and perform most of their activities right away. The first two weeks typically there is somewhat of a bruised feeling, but it doesn't interfere with their recreation or their work activities." Participants will return at three weeks, six weeks, 12 weeks, six months, and one year post-treatment. Their level of pain, level of activity, and work and recreational activities will be recorded. Olszewski will submit her findings and conclusions to a peer-reviewed podiatry journal.

The study is funded by a research grant from Artes. When asked how she became involved in the study, Olzewski said, "I am probably one of the only podiatrists in the Midwest that do injectable dermal fillers. I do use other products and I have for several years. I've used Sculptra, I've used Radiesse, and then Artefill came into the picture and [they] knew that I was doing this and they told me about their products and... [that] supposedly they are permanent. That interested us because nothing in the foot has been permanent so far. I approached them because it is a costly material, and insurance doesn't pay for this, and the patients are paying out of pocket. I said to them, 'Hey, would you be interested in doing a study?' They were very interested, and that's how we began the relationship."