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`The Top Ten Innovations In Podiatry | Podiatry Today
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`The Top Ten Innovations In Podiatry
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`Tuesday, 06/25/13 | 22215 reads
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`|S5Ue Number: Volume 26 — Issue 7 - July 2013
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`Author(s): Brian McCurdy, Senior Editor
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`Each year, podiatrlc physicians gain new tools to add to their armamentarlums to treat a variety of lower extremity conditions. Accordingly, this author speaks to experts
`in the field about new surgical advances, emerging wound care modalities, promising antifungals and a new line of OTC orthoses.
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`This year's innovations include a new extracellular matrix, more convenient negative pressure wound therapy (NPWT), advanced technology for ankle
`replacement, a cream to treat tinea pedis and the development of the first new topical treatment for onychomycosis in more than a decade. Without
`further ado, here is what our experts had to say.
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`Efinaconazole (Va|eant Pharmaceuticals). In the last decade or so, the flow of new agents for onychomycosis has slowed to a trickle. However,
`efinaconazole is a new player in the game. Warren Joseph, DPM, notes that if the Food and Drug Administration (FDA) approves the agent,
`efinaconazole will be the first new topical treatment for onychomycosis to receive FDA approval since ciclopirox 8% lacquer (Penlac) almost 15 years
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`ago.
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`“This will also, hopefully, usher in a new generation of potential topical therapies with a number of others currently in different phases of clinical trials, thus giving
`clinicians new choices on how to treat this difficult condition,” says Dr. Joseph, a Fellow of the Infectious Diseases Society of America and a consultant to Valeant.
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`As Richard Pollak, DPM, notes, efinaconazole is the first topical triazole antifungal for the treatment of distal lateral subungual onychomycosis. He cites high
`mycological cure rates in two studies, 55.2 percent and 53.4 percent respectively, calling the topical antifungal treatment “a viable alternative for the treatment of
`onychomycosis."
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`Dr. Pollak, a principal investigator in one of the aforementioned studies, also notes the treatment had a success rate of 44.8 percent in one study and 40.2 percent in
`another study.
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`“This topical agent is two to three times more effective than Penlac (Sanofi Aventis) and it has mycological cure rates and complete cure rates that are comparable to
`oral Sporanox (Janssen PharmaceuticaIs),” says Dr. Pollak, who is in private practice in San Antonio. “Since this a topical antifungal, it is not only safe but more
`efficacious than any currently available topical antifungals on the market."
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`As Dr. Joseph elaborates, the complete cure rate of efinaconazole was in the low to mid-20 percent range, comparing favorably to the same endpoint in the oral
`antifungal trials of itraconazole (14 percent), terbinafine (38 percent) and significantly higher than the only other approved topical, Penlac (5.5 to 8.8 percent).
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`Given that many patients are concerned about drug-drug interactions with oral antifungals and the possible risk of liver dysfunction, Dr. Pollak says the topical nature of
`efinaconazole is advantageous. Both he and Dr. Joseph say questions remain on drug pricing and insurance, and Dr. Pollak questions whether health management
`organizations will cover the drug once it is marketed or if insurers will ask practitioners to first try less efficacious topicals simply due to price concerns.
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`Dr. Joseph notes that the topical would only be approved for “mild to moderate” cases of onychomycosis so there will likely be no data on some of the more severe
`cases that podiatrists frequently see.
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`Onmel (Merz Pharmaceuticals). For another antifungal option, physicians may want to try a new dosing regimen for oral itraconazole. Onmel offers once daily dosing of
`200 mg of itraconazole, notes the manufacturer Merz Pharmaceuticals. The agent can treat onychomycosis due to Trichophyton rubrum or Trichophyton
`mentagrophytes in patients who are not immunocompromised, according to the company.
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`Tracey Vlahovic, DPM, has been using Onmel since last March. She says the once daily dosing of Onmel is a key advantage as it is more
`convenient for patients than pulse dosing, which is generally done with the generic oral itraconazole.
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`Dr. Vlahovic, an Associate Professor and J. Stanley and Pearl Landau Fellow at the Temple University School of Podiatric Medicine, does note that fit
`Onmel carries the same potential for drug interactions (with drugs such as Iovastatin and simvastatin) as other formulations of itraconazole. P
`In regard to contraindications for Onmel, Merz Pharmaceuticals notes the drug is contraindicated in pregnant patients, patients contemplating
`pregnancy and patients with evidence of ventricular dysfunction such as congestive heart failure or a history of congestive heart failure.
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`Cidacin (Pedicis Research). A new antifungal solution may get at the heart of tinea pedis. Cidacin can relieve the itching, burning, scaling and cracking that come with
`fungal infections, according to the manufacturer Pedicis Research.
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`Nicholas Romansky, DPM, cites Cidacin as innovative as it combines tolnaftate with dimethyl sulfoxide, which is well documented to penetrate the nail. He notes that
`most topical antifungals cannot penetrate the nail bed and the naiI’s deeper layers where the fungus resides and as a consequence, the infection remains active and is
`never fully eradicated.
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`“Cidacin, on the other hand, has the ability to penetrate because the dimethyl sulfoxide provides the transport to the deeper levels of the nail bed," says Dr. Romansky,
`who is in private practice in Media and Phoenixville, Pa. “Cidacin is really the only product to my knowledge that employs a logical solution to this problem and the proof
`is in the clinical results I have been observing."
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`Dr. Romansky, who has done unpaid product development for the product, has been using Cidacin for approximately six months and notes he has seen “clear nails in
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`as short as four months.”
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`1/9/2017
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`The Top Ten Innovations In Podiatry | Podiatry Today
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`Key Insights On Emerging Wound Care Products
`Endoform (Hollister Wound Care). An emerging extracellular matrix may be beneficial in treating a variety of acute and chronic wounds.
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`
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`Endoform is indicated for partial and full thickness wounds, diabetic ulcers, venous ulcers, pressure ulcers and chronic vascular ulcers. The
`exclusive distributor Hollister Wound Care notes that the Endoform dermal template contains a naturally derived ovine collagen extracellular matrix
`that is terminally sterilized. The company notes that the ovine origin may be more culturally acceptable than other animal-derived sources.
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`Hollister adds that the dressing contains 90 percent native, intact collagen and 10 percent extracellular matrix components. Matthew Garoufalis,
`DPM, FASPS, cites “very good results” after nine months of using the Endoform. He notes that the product also contains elastin, fibronectin, Iaminin
`_ and glycosaminoglycans. He also cites the product's unique structure with one side being a dense, contoured matrix and the other side being an
`open, smooth matrix.
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`Endoform also facilitates spectrum reduction of matrix metalloproteinases (MMPs) and its dermal template retains the structure and function of the patient‘s native
`extracellular matrix, notes the company. One may reapply the dressing once a week in comparison to collagen dressings that one must change more frequently. Hollister
`says the use of Endoform accordingly reduces cost and inconvenience for patients.
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`“It is a very robust product with good elasticity and high tensile strength,” notes Dr. Garoufalis, the President of the American Podiatric Medical Association. ‘‘It works
`very well in reducing MMP activity in the wound and yet is very, very cost-effective to use through weekly applications.”
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`Dr. Garoufalis cautions against using Endoform in patients with ovine sensitivity. He also would not use the product unless the wound had an adequate blood supply
`and was free of infection and necrotic material.
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`‘‘It otherwise appears to be a valuable weapon in our fight to heal chronic wounds,” says Dr. Garoufalis.
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`PICO (Smith and Nephew). For a more simplified and compact NPWT system, the PICO may be an effective post-op option for high-risk patients. Lawrence
`DiDomenico, DPM, FACFAS, who has used the system for eight months, says the PICO pulls away any post-op exudate and fluids, and wicks them into a dressing
`(holding up to 75 cc of fluid) until the one—week dressing change.
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`Citing good results with PICO, Dr. DiDomenico, the Director of the Reconstructive Rearfoot and Ankle Surgical Fellowship within the Ankle and Foot
`Care Centers and the Kent State University College of Podiatric Medicine, says the device is innovative as there has not been another post-op
`dressing that assists with incisions to prevent wound breakdown and wound dehiscence.
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`Physicians can easily apply the PICO, which distributes negative pressure across the wound bed at -80 mmHg, according to the manufacturer Smith
`and Nephew. The company adds that patients can carry the NPWT device in their pockets, which allows maximum mobility.
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`How Recent Innovations Can Facilitate Smoother Surgery
`TenFUSE PIP Allograft (Solana Surgical). A new sterile allograft is partially demineralized to maintain inductive and conductive properties. The manufacturer Solana
`Surgical says its TenFUSE PIP Allograft is sterilized to a sterility assurance level of 105, making the chances of contamination one in a million.
`
`In addition to citing the product's sterility as an advantage, Andrew Rice, DPM, says TenFUSE is rigid and reliable. After complete absorption, there
`is no trace of the allograft, according to Dr. Rice, who has been using TenFUSE for over a year.
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`Solana adds that the TenFUSE comes in configurations that are straight or angled at 10 degrees, and the device is tapered on the proximal end for
`easy insertion. The product also has a depth stop for accurate positioning and its octagonal shape and ridges resist rotation, according to the
`company.
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`The only downsides of the product are that one should avoid using it in patients with osteopenia or previous infection, according to Dr. Rice, an Assistant Clinical
`Professor in the Department of Orthopaedics and Rehabilitation at the Yale University School of Medicine. As he adds, “It isn't often that a surgeon can utilize a product
`that is engineered by nature.”
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`Prophecy Pre-Operative Navigation Guides (Wright Medical). Total ankle replacement can be a complex task but with the new Prophecy Pre-Operative Navigation
`Guides, surgeons can do the bulk of the planning before even picking up a scalpel.
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`With the Prophecy guides, the manufacturer Wright Medical says one can start surgical planning by loading preoperative computed tomography
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`anatomic landmarks without invasion of the tibial canal. The guides result from the information that surgeons provide. The company says with the
`guides, one can determine the following information before surgery: alignment and rotation, implant size and anterior/posterior femoral placement.
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`(CT) or magnetic resonance image (MRI) scans into a computer. Based on surgeon preferences, the company says the knee aligns with unobscured ¥
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`Christopher Hyer, DPM, has been using the Prophecy guides for two years. He says there are no other systems available that allow physicians to
`visualize the operative anatomy for total ankle replacement before surgery.
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`“This technology allows you to really perform the surgery in the virtual world before you ever get to the OR," says Dr. Hyer, a Fellow of the American College of Foot
`and Ankle Surgeons. “You are able to visualize the unique anatomy and pathology specific to that individual case.”
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`In comparison to performing a traditional total ankle replacement, Dr. Hyer says with the Prophecy guides, one can make decisions about implant sizing and
`positioning of the tibial tray, the number of stems, and the size of polyethylene space and the talar component before surgery. As he notes, this saves time and adds
`considerably to the efficiency in the OR. Dr. Hyer says the Prophecy guides also allow one to create patient specific cut guides to allow for precise implant placement.
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`Wright Medical notes that the Prophecy Pre-Operative Navigation Guides are completely extramedullary and may reduce blood loss and the incidence of pulmonary
`emboli. The company notes that the simplified ankle replacement process results in several simplified steps for OR staff: reduced tourniquet time; a reduced hospital
`sterilization process due to reduced instrument requirements; and less training for hospital staff.
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`Dr. Hyer adds a caveat that the technology requires a specific CT imaging protocol and its turnaround is about four weeks for the workup and computer simulation.
`However, he says this lead time is often not an issue in regard to total ankle replacement surgery. Dr. Hyer also notes that sometimes the CT images are compromised
`by preexisting hardware, which he says could adversely affect the ability of this templating protocol.
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`Tenex Health TX (Tenex Health). With the Fasciotomy and Surgical Tenotomy Technique in the Tenex Health TX, surgeons can use ultrasound technology to identify
`and debride pain-generating pathologic soft tissue in tendons and musculoskeletal structures of the foot and ankle, according to the manufacturer Tenex Health. The
`company says the Tenex Health TX uses the TX1 Tissue Removal System to address the lateral and medial epicondyle, the patellar tendon, the rotator cuff, the plantar
`fascia and the Achilles tendon.
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`Bob Baravarian, DPM, uses the TX1 ultrasound tissue debridement system for fasciosis, tendinosis and small loose bone pieces, calling it “great for
`plantar fascia and Achilles pain including insertional pain.“
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`Dr. Baravarian, the Chief of Podiatric Foot and Ankle Surgery at the Santa Monica UCLA Medical Center and Orthopedic Hospital, notes that the
`product removes the chronic scar tissue and increases blood to the region for healing in a percutaneous manner. He adds that it is minimally invasive
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`with no downtime for patients, who will wear a boot for two weeks after the procedure.
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`The company notes that Tenex Health TX is minimally invasive. It maintains that one can perform the technique with a local anesthetic and the treatment is done in 15
`minutes or less with a fast recovery.
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`Manos (Thayer Intellectual Properties). Plantar fasciotomy surgery can be truly minimally invasive thanks to a device that uses small entry and exit points, and results
`in no scarring.
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`Alexander Reyzelman, DPM, has used the Manos for three months to perform minimally invasive plantar fasciotomies. He notes the procedure uses one 14 gauge
`entry hole and a 17 gauge exit hole, and adds that patients can immediately bear weight postoperatively.
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`The manufacturer, Thayer Intellectual Properties, notes that the Manos procedure takes about 10 minutes. It adds that the procedure does not require general
`anesthesia, results in no scarring and stitches are not required.
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`“This product is truly geared for an ultrasound guided procedure in the foot," says Dr. Reyzelman. “Its design allows the surgeon to minimize injury to the surrounding
`tissue, decrease surgical time, and allow early weightbearing.”
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`While the Manos device is currently marketed for carpal tunnel syndrome, Dr. Reyzelman says a study looking at the use of the device for plantar fasciotomy was
`recently submitted for publication.
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`Could New Prefab Orthoses Have An Impact?
`Redi-Thotics (Redi-Thotics). A new brand of over-the—counter orthoses, tailored to different conditions and shoes, reportedly has many of the features and materials
`one might see with prescription orthoses.
`
`Nicholas Romansky, DPM, hails Redi-Thotics as “premium, well-made OTC devices.” He praises the kids’ device, the Awesome model, saying it provides motion
`control, support and comfort. His female patients like the comfort and width of the dress devices.
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`“My favorites are the Max for athletic golf and turf cleats," says Dr. Romansky, a Fellow of the American College of Foot and Ankle Surgeons. “For the athletic male or
`female athlete, these devices provide superior control, shock absorption and are very comfortable.”
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`Other available orthotic models, according to the manufacturer Redi-Thotics, are the Executive, for high heels and men's dress shoes; the Slim, which fits moderate
`arches; the Control for plantar fasciitis and heel spurs; the Ultra, a thin device for rigid, flat feet; Quik-Form, offering customized arch support; Balance, which has heat
`moldable comfort; and the Flex, for patients with metatarsalgia.
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