The Top Ten Innovations In Podiatry
- Volume 27 - Issue 7 - July 2014
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The manufacturer Valeant Pharmaceuticals cites two pivotal studies with the primary endpoint defined as complete clearance four weeks post-treatment. In the first study, 26 percent of patients treated with Luzu were completely cleared of tinea pedis in comparison to only 2 percent of people treated with the vehicle. The second study showed 14 percent of people treated with Luzu had completely cleared in comparison to only 3 percent of those treated with the vehicle.
Kerydin (Anacor Pharmaceuticals). A new class of topical antifungal for onychomycosis may debut on the market soon. Tavaborole (Kerydin) was the subject of a New Drug Application review from the Food and Drug Administration last fall and its Prescription Drug User Fee Act goal date is July 29, according to the manufacturer Anacor Pharmaceuticals.
The company notes that Kerydin has a boron-based mechanism of action and has enhanced nail penetration properties that deliver the compound to the nail bed.
Dr. Vlahovic notes clinical trials for the product focused on older patients with advanced nail disease who had positive results with Kerydin. In two phase 3 clinical trials, Anacor Pharmaceuticals says Kerydin achieved a high degree of statistical significance on all primary and secondary endpoints. The primary endpoint was complete cure (completely clear nail and negative mycology) of the target great toenail after 48 weeks of treatment, according to the company. About 600 patients with distal subungual onychomycosis participated in each study and applied either tavaborole solution or the vehicle to the target great toenail once daily for 48 weeks.
Dr. Vlahovic also notes that early in vitro data shows that one may use tavaborole in conjunction with nail polish.
“More research has to be done in this area but it is promising that our patients will be able to have the cosmesis covering of nail polish with the medicinal properties of Kerydin,” says Dr. Vlahovic, an Associate Professor at the Temple University School of Podiatric Medicine.
Can New Modalities Help Improve Healing In Wound Care?
CelluTome™ (KCI). With a new device, one may harvest epidermal skin grafts with little or no pain for the patient. The CelluTome produces a number of epidermal micrografts that are ready for immediate transfer onto a recipient site, notes the manufacturer KCI. Lee C. Rogers, DPM, notes that the system uses suction and heat for harvesting.
KCI says the CelluTome consistently harvests epidermis at the dermal-epidermal junction, including basal keratinocytes. The harvesting procedure raises uniform microdomes and the company adds that the micrografts harvested contain undamaged tissue, evidenced by the cells growing outward from the micrograft edge.
When using the CelluTome device, Dr. Rogers notes that most patients will have no pain while others may experience a mild tugging or pulling. He says the CelluTome causes about 100 tiny blisters that one can subsequently cut with a disposable blade and transfer to a Tegaderm dressing. The clinician can then transfer the Tegaderm and islands of epidermis to the foot, notes Dr. Rogers, the Medical Director of the Amputation Prevention Center at the Sherman Oaks Hospital in Sherman Oaks, Calif.
“CelluTome is a novel device that allows a doctor to harvest a skin graft in the clinic (as opposed to the OR) without anesthesia. It has the potential to change the landscape in diabetic foot ulcer treatment,” says Dr. Rogers.
PriMatrix Ag (TEI Biosciences). The antimicrobial power of silver fuels an emerging skin substitute.