Study Tests Dermal Filler for Pain Due to Fat Pad Loss

Tag : shoes pad
Study Tests Dermal Filler for Pain Due to Fat Pad Loss

A Chicago podiatrist has announced a pilot study to test apurportedly permanent, injectable dermal filler for treating footpain due to fat-pad loss in the plantar metatarsal area. MaryOlszewski, DPM, American Board of Podiatric Orthopedic &Primary Podiatric Medicine, will evaluate the effects of ArteFillon pain and activity levels in fat-pad-loss patients who reportfoot 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 collagengel, and a small amount of lidocaine, saline, and a phosphatebuffer. It is the first injectable dermal filler containing PMMA tobe approved by the U.S. Food and Drug Agency (FDA), and wasapproved in 2006 for a cosmetic use--filling nasolabial folds. Ithas been approved for use in Canada since 1991. According to a June2003 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 carriersubstance that prevents the microspheres from agglomerating duringtissue ingrowth. The 20 volume percent of microspheres in Artefillprovides the scaffold for the 80 percent volume of connectivetissue deposition, a complete replacement of the injectedcollagen." The recipient's connective-tissue regrowth around themicrospheres is the cause of Artefill's claimed non-migration, andPMMA is not absorbed or known to degrade in the human body. TheFDA's Summary of Safety and Effectiveness Data for Artefill statesthat adverse events recorded for Artefill occur at a rate similarto other injectable dermal fillers. They include "persistentswelling or redness, lumpiness at injection site more than onemonth 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 herown practice in the second half of 2008. ArteFill will be injectedsub-dermally in the entire metatarsal area of one foot, leaving thecontralateral foot as a control. According to Olszewski,participants are likely to be able to "walk and perform most oftheir activities right away. The first two weeks typically there issomewhat of a bruised feeling, but it doesn't interfere with theirrecreation or their work activities." Participants will return atthree weeks, six weeks, 12 weeks, six months, and one yearpost-treatment. Their level of pain, level of activity, and workand recreational activities will be recorded. Olszewski will submither findings and conclusions to a peer-reviewed podiatry journal.

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