Each year, podiatric physicians gain new tools to add to their armamentariums 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.
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.
Efinaconazole (Valeant 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 ago.
“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.
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.”
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.
“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 Pharmaceuticals),” 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.”
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).
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.
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.
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.
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.
Dr. Vlahovic, an Associate Professor and J. Stanley and Pearl Landau Fellow at the Temple University School of Podiatric Medicine, does note that Onmel carries the same potential for drug interactions (with drugs such as lovastatin and simvastatin) as other formulations of itraconazole.
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.
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.
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 nail’s deeper layers where the fungus resides and as a consequence, the infection remains active and is never fully eradicated.
“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.”
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 as short as four months.”
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.
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.
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, laminin 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.
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.
“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.”
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.
“It otherwise appears to be a valuable weapon in our fight to heal chronic wounds,” says Dr. Garoufalis.
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.
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.
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.
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 10-6, 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.
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.
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.”
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.
With the Prophecy guides, the manufacturer Wright Medical says one can start surgical planning by loading preoperative computed tomography (CT) or magnetic resonance image (MRI) scans into a computer. Based on surgeon preferences, the company says the knee aligns with unobscured 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.
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.
“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.”
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.
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.
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.
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.
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.”
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 with no downtime for patients, who will wear a boot for two weeks after the procedure.
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.
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.
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.
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.
“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.”
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.
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.
“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.”
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.