Unveiling The Top Ten Innovations

By Jeff Hall, Editor-in-Chief

Intriguing new treatments and devices abound in this yearly review. We take a closer look at promising therapies for diabetic neuropathy and osteoarthritis of the ankle. Wound care specialists weigh in on new approaches to optimizing wound beds and closing stubborn wounds. Podiatric surgeons discuss time-saving devices for facilitating tendon transfers and leading voices in biomechanics offer their respective takes on a helpful orthotic modification, a re-emerging pediatric orthotic and a new athletic shoe that is generating a lot of buzz. Without further delay, here is what the experts had to say … 1. Ruboxistaurin mesylate (Eli Lilly). Could a newly emerging medication reverse the damage of diabetic peripheral neuropathy? Ruboxistaurin mesylate, which has been the subject of worldwide studies on diabetic neuropathy as well as diabetic retinopathy, has shown early promise, according to various researchers. The drug is an inhibitor of protein kinase C (PKC) Beta II, which has been shown to be “overactive in the tissues targeted by diabetes and responsible for impairment of microvascular function,” explains Aaron I. Vinik, MD, a Professor of Internal Medicine at Eastern Virginia Medical School in Norfolk, Va. In these cases of impaired microvascular function, the nerves are vulnerable to compromised blood supply, which can lead to initial nerve dysfunction and subsequent irreversible nerve damage, according to Dr. Vinik. However, he notes that as an inhibitor of PKC Beta II, ruboxistaurin mesylate has “the capability of reversing or preventing the biologic abnormalities in diabetes” as opposed to just treating a symptom of diabetes such as hyperglycemia. Dr. Vinik emphasizes that this medication, which is currently in Phase III development, could have a major impact in the podiatric diabetic population. “There are 85,000 amputations each year in the United States alone,” points out Dr. Vinik. “Eighty-seven percent of the time, the main predisposing factor is neuropathy, which leads to foot ulcers, infections, osteomyelitis and neurodegenerative arthropathy (Charcot). (With the use of ruboxistaurin mesylate), I think the podiatric diabetic population may be relieved of a considerable proportion of this morbidity and potential for the loss of quality of life and premature death.” Bring In The Wound Closers 2. Graftjacket and Graftjacket Xpress (Wright Medical). Earlier in the year, researchers published a study in Orthopedics that examined the use of Graftjacket Regenerative Tissue Matrix on full-thickness wounds in patients with diabetes (see page 13, “News And Trends,” March issue). In the 40-patient study, the authors found that those treated with the Graftjacket had an 89.1 percent reduction in wound depth after a month whereas the control group had a 25 percent reduction within the same time period. David G. Armstrong, DPM, says he has also had favorable results with the modality. “The Graftjacket seems to be very useful as a durable, predictable scaffold for wounds of moderate depth,” says Dr. Armstrong, a Professor of Surgery, Chair of Research and Assistant Dean at the William M. Scholl College of Podiatric Medicine at Rosalind Franklin University of Medicine in Chicago. Dr. Armstrong, a member of the National Board of Directors of the American Diabetes Association, has also been impressed with the Graftjacket Xpress Flowable Soft Tissue Scaffold. He says he has found it useful for tunneling wounds. According to the manufacturer, the Graftjacket Xpress is an injectable treatment that is mixed with sterile saline. The company says one would apply Graftjacket Xpress to deep crevicing wounds via a syringe through a small catheter. It emphasizes that the product reduces the risk of infection and facilitates the rapid formation of granulation tissue. Dr. Armstrong has found both modalities to be “very promising,” noting that he has seen a synergy of the two products in deep, complex wounds with elements of undermining. A New Approach To Debridement? 3. Versajet (Smith and Nephew). Recently approved by the FDA, the Versajet is a new technology that enables one to perform surgical debridement via a high-pressure stream of saline and vacuum effect that removes non-viable tissue from the wound. Alan Cantor, DPM, CWS, has used the Versajet over the past year on a regular basis for debriding diabetic, burn and surgical wounds. Dr. Cantor says the Versajet offers several benefits to clinicians. “The hydro benefit does not desiccate, burn or cauterize tissue,” notes Dr. Cantor, an Attending Surgeon in the Burn and Wound Center at the Nassau University Medical Center in East Meadow, N.Y. “It gives you a very clear appreciation of the wound field and allows you to easily see if there is any additional tissue that needs to be debrided.” The ability of the device to simultaneously debride the wound and vacuum in airborne debris is “very significant,” according to Dr. Cantor, a faculty member of the Oxford University Wound Healing Institute in the United Kingdom. “Numerous articles and data show airborne contaminants remain in the air 30 minutes after dressing changes,” explains Dr. Cantor. “The fact that the Versajet can debride and remove airborne contaminants at the same time is particularly beneficial when graft procedures are taking place.” John Steinberg, DPM, has used the device for three months and has employed it on wounds in place of or in combination with sharp debridement. However, Drs. Cantor and Steinberg strongly caution that using the Versajet involves precision surgery and the device should not be confused with pulse lavage. Dr. Cantor says a lack of familiarity with the device can cause harm. “There is a definite learning curve in getting used to how much tissue the instrument will debride,” emphasizes Dr. Steinberg, an Assistant Professor within the Department of Orthopaedics, Podiatry Division at the University of Texas Health Science Center in San Antonio, Tx. “However, the device is a powerful and efficient debridement tool when it is used properly.” Is There An End In Sight For The Frustration Of Passing A Tendon Through Bone? 4. TenDone! Device (Biopro). Whether they are performing tendon transfer, suspension or advancement procedures, podiatric surgeons say one of the most frustrating and time-consuming aspects of these procedures is attempting to pass a stump or end of the tendon through the entrance of a bony channel. However, the emergence of the TenDone!, a tendon passing device comprised of a flexible metallic guide and a nylon net, may go a long way toward eliminating this common frustration. Daniel K. Lee, DPM, says the device addresses the previous problems of obtaining an appropriate suture hold on the tendon and the risk of potential damage to the tendon from either the suture or attempting to pass it through the bony channel. “The guide adapts to the geometry of the bony channel even in areas of difficult access,” points out Dr. Lee, an Associate of the American College of Foot and Ankle Surgeons. “It also allows for a rapid attachment of the tendon without any damage and provides for a smaller and firmer interface between tendon and bone.” He says the device, which follows the principles of a Chinese finger trap, is “simple to use and has very little learning curve.” Dr. Lee says the device can also reduce surgical time for procedures (i.e. posterior tibial tendon advancement, lateral ankle stabilization, etc.) that involve tendon manipulation. In the past, Dr. Lee notes that preparation and manipulation for tendon transfers after they have been harvested could take anywhere “between five to 30 minutes,” depending on a host of factors including the specific procedure, the specific tendon, the quality of the tendon and the availability of instrumentation. “With the TenDone! method, it usually takes me about one minute or less to complete the tendon transfer,” says Dr. Lee, a faculty member of the Baja Project For Crippled Children and the Los Angeles County and University of Southern California Medical Center in Los Angeles. Another Option For Facilitating Tendon Transfers 5. The Bio-Tenodesis Screw (Arthrex). Alan Catanzariti, DPM, says he typically employs a flexor hallucis tendon transfer during the repair of a chronic or delayed rupture of the Achilles tendon, especially when there is obvious muscle weakness or a significant loss of muscle power. However, his use of the Bio-Tendodesis Screw over the past year has changed his approach to this procedure. In the past, Dr. Catanzariti would harvest the flexor hallucis longus (FHL) tendon from the medial longitudinal arch distal to the master knot where it attaches to the flexor digitorum longus. However, he says this is no longer necessary with this absorbable anchor because less tendon length is required. “One can now harvest the FHL tendon from the posterior ankle with sufficient length for tenodesis,” explains Dr. Catanzariti, the Director of Residency Training Programs for the Division of Foot and Ankle Surgery at the Western Pennsylvania Hospital in Pittsburgh, Pa. “This eliminates dissection of the medial longitudinal arch and decreases operating time.” Dr. Catanzariti, a Fellow of the American College of Foot and Ankle Surgeons, also notes that this procedure is “technically much simpler to perform.” While potential drawbacks include the requirement for the material to be absorbed, Dr. Catanzariti says he has not experienced any problems during the time that he has used the absorbable surgical anchor. Insights For Curbing Symptoms Caused By Excessive Supination 6. Lateral heel skive. One orthotic modification that appears to be emerging in podiatry is the lateral heel skive, which has proven to be useful in treating patients who have excessive supination moments across the subtalar joint (STJ), according to Kevin A. Kirby, DPM. Dr. Kirby says the lateral heel skive is a positive cast modification technique that is very similar to the medial heel skive that he first described 12 years ago.1 While the principles are the same, Dr. Kirby notes the medial heel skive creates a varus heel wedge whereas the lateral heel skive involves shaving plaster from the lateral-plantar aspect of the heel of the positive cast in order to create a valgus heel wedge. “Mechanically, the lateral heel skive increases the STJ pronation moment in feet that have symptoms and/or pathology related to excessive STJ supination moments, and will therefore help to speed recovery in these patients,” explains Dr. Kirby, an Adjunct Associate Professor within the Department of Applied Biomechanics at the California School of Podiatric Medicine at Samuel Merritt College. When using the lateral heel skive, Dr. Kirby strongly encourages combining it with other anti-supination orthosis modifications such as everted cast balancing positions and/or valgus forefoot extensions and lateral longitudinal arch fillers on the orthosis. In his experience, Dr. Kirby has found that using the lateral heel skive in concert with other anti-supination orthosis modifications facilitate “very effective treatment of chronic peroneal tendinitis/tendinosis without braces or surgery in many instances.” Additionally, he notes these combined modifications can be effective in treating lateral ankle instability and chronic dorsal midfoot pain along the lateral column of the foot. “(Using these combinations helps) reduce the pathological rotational forces that are the mechanical etiology of these patients’ symptoms,” says Dr. Kirby. To date, Dr. Kirby says he has not seen any potential drawbacks related to the lateral heel skive and adds that it is well tolerated by patients. Taking A Closer Look At A Pediatric Prefab Orthotic 7. Kiddythotic (ProLab). While the Kiddythotic originally made its debut in 1994, Russell G. Volpe, DPM, believes this pediatric prefabricated orthosis may re-emerge as a cost-effective innovation. He says it is “truly superior” to most pediatric prefabricated devices that “are too soft and lack sufficient control for children who have a pes valgus.” Dr. Volpe says the Kiddythotic offers several design features that make it a “very effective” prefabricated substitute for a motion-controlling custom foot orthosis for use in children. He says the features include: • semi-rigid polypropylene that resists compression of the medial longitudinal arch; • a shell that incorporates a slight medial flange and a deep heel cup to increase surface area of the orthosis medial to the subtalar axis; • a 4-mm medial heel skive that applies increased force medial to the subtalar axis; and • 3 degrees of forefoot valgus correction to help lock the midtarsal joint and enhance first MPJ dorsiflexion. “These design features were selected in order to apply an orthotic reaction force (ORF) medial to the subtalar joint axis, which facilitates a supinatory torque around the axis,” explains Dr. Volpe, the Chair of the Department of Pediatrics, and a Professor in the Departments of Pediatrics and Orthopedics at the New York College of Podiatric Medicine. “Many of these features in the Kiddythotic were previously only used in custom foot orthoses.” Dr. Volpe notes the primary indication for the Kiddythotic is pediatric pes valgus when a custom device is either not necessary (due to a mild or moderate condition) or when financial considerations make a prefabricated device more practical. He says the device is also useful when parents of toddlers are concerned about the frequency of out-grows that a young child may go through with custom orthoses. “The Kiddythotic is available in enough sizes to cover the toddler taking his or her first steps through the preschool age child,” points out Dr. Volpe, who has a pediatric foot and ankle specialty practice in New York and Farmingdale, N.Y. While Dr. Volpe was always dissatisfied with other pre-fab devices for children, he has been pleased with the results he has seen with the Kiddythotic. “It works very well at controlling the compensated foot and encouraging improved function of the child,” notes Dr. Volpe. “Children have little or no problem adjusting to it and it fits very well in shoes.” Will This Running Shoe Be The One? 8. “1” (Adidas). In December, Adidas will reportedly launch a new running shoe called “1” with embedded computer technology that allows the shoe to adapt its cushioning while the athlete runs. From what he has read about the “smart shoe,” Douglas Richie, Jr., DPM, says the heel of the shoe reportedly has a built-in sensor and magnet that measure compression at each foot strike and then link to a motor-driven cable within the shoe’s sole to regulate compression. “Therefore, the overall cushioning of the shoe is continuously modified over the course of the run in order to keep the ‘ideal cushioning’ consistent for the runner,” explains Dr. Richie, the President-Elect of the American Academy of Podiatric Sports Medicine. However, Dr. Richie has a few reservations about the shoe, which may retail between $250 and $300 according to different reports. While he has not seen nor tested the shoe, Dr. Richie points out the role of impact remains unclear when it comes to running injuries despite considerable research on the subject. He says there is no consensus in the scientific community on an ideal amount of cushioning needed to prevent injury. Dr. Richie also points out individuals vary significantly in terms of their cushioning needs and that over-cushioning of athletic footwear can actually increase the risk of injury. “If the scientific community is not in agreement about optimal levels of cushioning, how can a shoe be specifically ‘calibrated’ to provide the perfect cushion to a runner?” posits Dr. Richie, an Adjunct Associate Professor of Biomechanics at the California School of Podiatric Medicine at Samuel Merritt College. He also notes that several studies have shown that athletes perform better when their impact and movement patterns are varied during the course of a workout. While Dr. Richie admits the shoe has the potential for strong customer appeal, he says “the jury is still out on whether a smart shoe can actually prevent running injuries.” What About Bleomycin Injections For Recalcitrant Warts? 9. Bleomycin injections. If a variety of other treatments have failed to resolve a recalcitrant wart, Thomas Chang, DPM, says it may be worthwhile to consider the use of bleomycin injections. In the May supplement, “A Closer Look At Wart Treatment,” Dr. Chang noted that bleomycin is a cytotoxic polypeptide that has anti-viral, anti-tumor and anti-bacterial properties. Bleomycin injections inhibit DNA synthesis and necrose the nutrition blood supply to these lesions, according to Dr. Chang, the Chief of the Podiatry Department at the Sutter Medical Center in Santa Rosa, Ca. In the aforementioned supplement, Dr. Chang emphasized that he reserves this treatment as his “last approach to the most resistant recalcitrant warts,” but noted that bleomycin injections have one of the highest cure rates in the literature for treating warts. “Injecting bleomycin within the wart tissue seems to be dramatic in resolving the warts that are really tough to resolve and have failed other multiple treatments,” points out Dr. Chang, a Clinical Professor at the California School of Podiatric Medicine at Samuel Merritt College and a Fellow of the American College of Foot and Ankle Surgeons. Is There A New Option For Relieving Osteoarthritis Of The Ankle? 10. Hyalgan (Sanofi-Synthelabo, Inc.). Thousands of patients suffer from osteoarthritis and many opt for surgical intervention or long-term NSAID use for relief. However, Robert Salk, DPM, says injections of intraarticular sodium hyaluronate (Hyalgan) may be an effective and safer alternative. While sodium hyaluronate is FDA-approved for osteoarthritis of the knee, Dr. Salk says using these injections off-label to treat osteoarthritis of the ankle has shown promise. “We have had excellent success with this treatment,” emphasizes Dr. Salk, the Director of Research at the Northern California Foot and Ankle Center. Earlier this year at the annual meeting of the American College of Foot and Ankle Surgeons, Dr. Salk presented an abstract of a randomized, double-blind clinical trial that examined using weekly injections of sodium hyaluronate over a five-week period to treat osteoarthritis of the ankle. Dr. Salk and his colleagues found that 71 percent of the patients treated with sodium hyaluronate had “clinically significant improvement” as opposed to 43 percent of the patients in the placebo group, who received injections of phosphate buffered saline. In the abstract, the authors note that sodium hyaluronate injections provide “sustained relief of pain” and may facilitate improved ankle function.



References 1. Kirby, KA. The medial heel skive technique: improving pronation control in foot orthoses. JAPMA, 82:177-188, 1992.


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