The Top Ten Innovations In Podiatry

Podiatric technology continues to advance and the profession has seen recent innovations in areas such as wound care, surgery and the diabetic foot. Experts in various aspects of podiatry provide insights on acellular dermal matrices, a hammertoe implant, a diabetic insole and other podiatric advances.

Podiatric physicians continue to reap the benefits of improved technologies. In our annual review of the latest innovations in the field of podiatry, there are products that allow enhanced efficiency in the OR, improved patient adherence and more timely delivery of appropriate antibiotic medications. Certainly, the hope for any of these innovations is to facilitate better treatment outcomes for patients. Without further delay, here are the latest innovations.

   1. Oasis® Ultra Tri-Layer Matrix (Healthpoint Biotherapeutics). A new version of an extracellular matrix, the Oasis Ultra, now contains three layers of porcine small intestinal submucosa (SIS). The manufacturer, Healthpoint Biotherapeutics, notes the three layers incorporate increased structure into chronic and difficult to heal wounds. The company notes the three layers are 300 microns thick, three times the thickness of single-layer Oasis.

   Gary Rothenberg, DPM, recently started using Oasis Ultra and cites good success. He has used single layer Oasis for years but says the tri-layer product has the advantages of improved thickness and durability for use in deeper wounds in comparison to the single layer version.

   Dr. Rothenberg says Oasis Ultra also has the advantages of simple application and a longer shelf life over competitors such as Apligraf (Organogenesis), Dermgraft (Advanced BioHealing), MatriStem (Medline Industries), Graftjacket (KCI) and Integra (Integra Life Sciences). He notes that Oasis is pre-fenestrated and requires no thawing, major rehydration or suturing. As Dr. Rothenberg notes, one just places the extracellular matrix on the wound, moistens it with saline and secures with Steri Strips.

   “I see it as a simple, user-friendly product in the category,” says Dr. Rothenberg, the Director of Residency Training and an Attending Podiatrist with the Miami Veterans Affairs Healthcare System.

   The only potential downside, notes Dr. Rothenberg, is that the Oasis Ultra comes in fairly large sizes of 7 x 10 cm and 7 x 20 cm, and one must purchase it in boxes of five. He says the 7 x 10 size provides enough product for about four applications of the “typical” diabetic foot ulcer so he has applied the product and then had to assign the piece to a specific patient and keep track of it from week to week. However, Dr. Rothenberg says this is a minor drawback.

   Healthpoint Biotherapeutics notes that Oasis Ultra is indicated for surgical wounds, partial- and full-thickness wounds, traumatic wounds (including second degree burns), venous ulcers, chronic vascular ulcers, diabetic and pressure ulcers and draining wounds. Dr. Rothenberg cautions against using Oasis Ultra in patients with an allergy to porcine products or those with an active infection. In addition, Healthpoint Biotherapeutics notes the product is not indicated for the treatment of third-degree burns.

   Dr. Rothenberg is looking forward to gaining more clinical experience with the product and seeing more clinical evidence on its efficacy.

A More Portable, Patient-Friendly Version Of NPWT

2. VAC Via™ (KCI). When it comes to negative pressure wound therapy (NPWT), some patients may complain that the NPWT devices are too large, loud and conspicuous. The portable, quiet VAC Via may obviate such concerns and make for a more pleasant patient experience.

   The VAC Via is an “evolutionary” product that makes NPWT more patient friendly and available to more patients, notes Kazu Suzuki, DPM, CWS. He notes the device is small, light, almost silent and powered by a battery with a charge that lasts seven days. Patients can conceal the device as it is attached to their waistline and Dr. Suzuki notes this protects patients’ privacy, letting them benefit from NPWT in a discreet manner. Furthermore, he says patients can discard the VAC Via after completing therapy.

   The manufacturer, KCI, notes that the VAC Via provides the same benefits as its other Vacuum Assisted Closure (VAC) devices, including maintaining a moist wound healing environment, removing infectious material and promoting granulation and perfusion.

   The VAC Via’s battery is an advantage, says Dr. Suzuki, who notes that traditional VAC therapy devices and most NPWT products contain heavy NiCd rechargeable batteries. Some of his patients are frail with many weighing 100 pounds or less, and he considers them at risk for a fall if they wear a 10-pound medical device.

    “It is a big advantage to our patients that VAC Via contains a mechanical pump that is the size of a quarter coin and virtually silent,” comments Dr. Suzuki, the Medical Director of the Tower Wound Care Center at the Cedars-Sinai Medical Towers. “I put my ear next to VAC Via after starting the pump and I could not even hear any suctioning noise at all, even though the pump was working at 125 mmHg suction.”

   In addition, KCI notes the portability of the device enhances patient adherence and decreases the length of stay for patients at hospitals.

   Dr. Suzuki notes each VAC Via device costs approximately $500 per unit for seven days of NPWT therapy. He says the details of insurance reimbursements are still pending but the devices are available now for purchase. Dr. Suzuki anticipates that many hospitals will start using VAC Via as a part of discharge plans for those who need negative pressure wound therapy.

What You Should Know About New Surgical Solutions

3. Pro Toe™ VO Hammertoe Implant System (Wright Medical). For patients who need hammertoe correction, the Pro Toe VO Hammertoe Implant System may offer durable correction without K-wires sticking out of the toe.

   Christopher Hyer, DPM, FACFAS, has used the Pro Toe for nine months and participated in the product’s pre-market trials. He praises the product’s durability, one-piece design and simplicity of use. Dr. Hyer adds that one can use the Pro Toe off the shelf with no need for other instrumentation.

   The Pro Toe provides solid fixation and stability of hammertoe repair with little chance of recurrence, according to Dr. Hyer. He says the device has a straight and angled design that allows surgeons to “dial the correction in” as needed.

   Unlike with K-wires, the Pro Toe does not leave hardware sticking through the skin, which can cause infection or pain due to something hitting the K-wire, according to Dr. Hyer. He says the Pro Toe also obviates patient anxiety about the discomfort and appearance of K-wires as well as wire removal and the risk of recurrent deformity following removal.

    “Patients much prefer having a retained, internal implant that they do not see sticking out of the toe and that stays inside keeping the toe straight,” says Dr. Hyer, a board-certified foot and ankle surgeon who practices in Columbus, Ohio.

   The manufacturer, Wright Medical, notes the Pro Toe is indicated for the fixation of osteotomies and for reconstruction of the lesser toes following corrective procedures for hammertoe, claw toe and mallet toe. The company notes that the implant has a blade-style end as well as a threaded end and is available in two sizes with two blade angles.

   In Dr. Hyer’s opinion, the Pro Toe is better than other hammertoe implants as it is one piece, not two, so there is no connection point that may fail and come unlocked. Another advantage is that the implant is made of strong stainless steel in comparison to other implants made of nitinol, which Dr. Hyer says can be weak. While one can use Pro Toe right out the package, he notes other implants must be stored in a deep freezer and have a limited working time, or require an expensive generator to “activate” the metal implant.

   Surgeons should use the Pro Toe when trying to attain fusion of the proximal interphalangeal joint or a pseudarthrosis, according to Dr. Hyer, the Director of the Advanced Foot and Ankle Reconstruction Fellowship at the Orthopedic Foot and Ankle Center in Westerville, Ohio. Accordingly, if a patient wanted to have a joint that is still flexible, one would not use an implant, according to Dr. Hyer. He says a relative contraindication may be a toe with very small bones, particularly the middle phalanx. In some cases, Dr. Hyer says the bones of the fifth toe are really small and do not provide enough bone for one to use an internal implant.

   4. TarsX Intramedullary Midfoot Fusion Device (Extremity Medical). Are you looking for better compression for midfoot fusion procedures? A new total intramedullary implant may prove to be beneficial in this regard.

   For about a year, Ron Raducanu, DPM, has used the TarsX Intramedullary Fixation System for midfoot Charcot reconstruction and Lapidus fusion. He notes the system’s instrumentation system is designed for maximum compression and stabilization.

    “I believe (the TarsX) affords superior compression to the conventional methods of fixation for midfoot fusions,” says Dr. Raducanu, who is in private practice in Virginia Beach and Norfolk, Va.

   In addition, Dr. Raducanu notes the current techniques for Charcot reconstructions revolve around external fixation frames, which have a high morbidity rate among the population for this procedure.

   The manufacturer, Extremity Medical, says the TarsX implant provides stable fixation and minimizes wound complication related to hardware, according to the company. Extremity Medical also says the product enables surgeons to fuse multiple joints up to the talus if desired. Surgeons also have the capability with the TarsX device to fuse all five rays, according to the company.

   Dr. Raducanu adds that the product has a moderately high learning curve. He also notes the device has gone through some design iterations as it is relatively new. Furthermore, Dr. Raducanu says the presence of very soft bone makes fixation “a little tricky.”

A Quicker Turnaround On MRSA And MSSA Diagnosis

5. KeyPath MRSA/MSSA Blood Culture Test (MicroPhage). Given the prevalence of methicillin resistant Staphylococcus aureus (MRSA) and its potential impact in high-risk populations, it can be valuable for healthcare facilities to have a test to help facilitate a quicker diagnosis of MRSA and methicillin sensitive Staphylococcus aureus (MSSA).

   While it may take 48 to 72 hours to hear back on conventional culture results, the KeyPath MRSA/MSSA Blood Culture Test can reportedly identify and differentiate MSSA from MRSA from gram-positive blood cultures in five and a half hours, according to MicroPhage, the manufacturer of the test.

    “Whatever we can use to rapidly assess the difference between MRSA and MSSA will be helpful, provided the price is right for this screening test,” says David G. Armstrong, DPM, PhD, MD, a Professor of Surgery at the University of Arizona College of Medicine in Tucson, Ariz.

   MicroPhage notes the KeyPath test, which recently received FDA clearance, can facilitate earlier antimicrobial therapy, decrease the length of hospital stays and is cost effective. The company adds that the test uses true phenotypic aspartate aminotransferase (AST) results and results are drawn directly from the blood culture.

   The KeyPath test will potentially reduce the complexity of care on patients and therefore benefit the greater healthcare system, notes Dr. Armstrong. He says the test will also help lower the cost of MRSA drugs and help doctors deliver the right drugs to patients in a more expeditious manner.

A Closer Look At New Acellular Dermal Matrices

6. MemoDerm™ Acellular Dermal Matrix (MMI). An emerging acellular dermal matrix, the MemoDerm, may facilitate the treatment of wounds in areas such as the Achilles tendon and the lateral ankle complex as well as chronic diabetic foot ulcers.

   Andrew Rice, DPM, FACFAS, says bioengineered alternative tissue human dermal products to date have been non-sterile, thick and are typically not meshed. He notes that MemoDerm provides a sterile cadaveric human dermis allograft with preserved collagen I, III, IV, VII, proteoglycans and elastin. In addition, Dr. Rice says MemoDerm can reduce OR time as other products may require a prolonged time of saline immersion prior to their application.

    “(The product’s sterile nature) may significantly reduce the risk of septic complications, particularly in high-risk populations such as our diabetic patients,” notes Dr. Rice, an Assistant Clinical Professor in the Department of Orthopedic Surgery and Rehabilitation at the Yale University School of Medicine.

   Memometal (MMI), the manufacturer of the product, says the unique sterilization processing method of MemoDerm removes the epidermal layer and cellular elements, which minimizes the potential for an immunogenic response. The company says the acellular dermal matrix preserves the natural histomorphology.

    “The thinner nature to this biologic product and the meshed pattern facilitate rapid cellular revascularization and repopulation, giving this biologic product more rapid regenerative properties,” comments Dr. Rice, who is board certified in foot and ankle surgery by the American Board of Podiatric Surgery.

   Since the product is available in various sizes and thickness, Dr. Rice says the tissue can act more readily as a matrix bridge for vascular migration, whether you are using it for tendon supplementation or diabetic foot wound healing.

   Dr. Rice notes that MemoDerm is contraindicated in patients with active soft tissue and/or active bone infection. He says it is also contraindicated in ischemic wounds prior to revascularization.

7. DermaSpan™ Acellular Dermal Matrix (Biomet Sports Medicine). DermaSpan, a new acellular dermal matrix derived from allograft human skin, is supplied sterile, according to the manufacturer Biomet Sports Medicine. The company notes that DermaSpan is one of the few acellular dermal matrices to be irradiated under a validated sterilization process.

   The company adds that the product’s sterile nature further decreases the risk of disease donor transmission and notes that laboratory testing has shown the use of an acellular dermal matrix leads to a lower risk of an inflammatory response. Biomet also notes that DermaSpan has high suture pull-out strength and does not require refrigeration.

   Anthony V. Borgia, DPM, FACFAS, has used DermaSpan for a few months and praises the fact that the product has cuts of uniform thickness no matter what size one uses.

    “It continues to enhance my practice by providing a product for my patients that has science and a proven history behind it to optimize healing,” says Dr. Borgia, the Chief of the Podiatric Section in the Department of Surgery at University Medical Center in Las Vegas.

   Dr. Borgia notes that this type of human dermis has no foreign body effect after transplantation into allogeneic hosts. He says DermaSpan’s growth factors and structural skeletal matrix are components that the human body recognizes and can expedite the healing process. Dr. Borgia adds that one can use DermaSpan directly on bone unlike heterogeneous grafting tissue. He says this is very helpful when the chronic ulcer involves bone since other similar products do not have FDA approval for bone involvement.

   One can also use the dermal matrix directly on tendons to reinforce augmentation procedures or to replace tendon with acute or secondary damage, according to Dr. Borgia. He says the host site will incorporate DermaSpan as its own tendon tissue with time.

    “After a couple years, it is almost impossible to distinguish the composite histologically from the patient’s own tissue,” notes Dr. Borgia.

Offloading The Diabetic Foot With Custom Inserts

8. XFit Diabetic Inserts (PAL Health Technologies). Offloading plays a valuable role in facilitating diabetic foot ulcers. XFit Diabetic Inserts utilize foot scanning to create inserts customized to the shape of the foot.

   Lee C. Rogers, DPM, notes that the XFit is the first custom temporary insole created from a scan of a foot. After scanning the foot, he says one would send the wound images to the central lab, which has a 24-hour turnaround time. The resolution of the wound scan is 150 points per inch, which allows for precise construction of the offloading insert, according to Dr. Rogers. As he notes, the doctor indicates which diabetic walker the patient is using and the insert is customized to the walker or post-op shoe.

   The insoles can be composed of many materials but Dr. Rogers says the temporary insoles are usually made of Plastazote with a top cover. The manufacturer, PAL Health Technologies, notes that each insert comes with a Microcell Puff 35 durometer shell and a 1/8-inch Plastazote cushioning layer. The company adds the insert has optional metatarsal pads and fills to accommodate amputations. In addition, PAL says the insoles can accommodate patients of any weight and one can prescribe them for extra-depth shoes.

   After the wound heals, one can obtain a repeat scan and create custom insoles for shoes with more durable material, according to Dr. Rogers, the Associate Medical Director of the Amputation Prevention Center at Valley Presbyterian Hospital in Los Angeles.

Exploring The Potential Of Emerging Graft Products

9. Plexur M Innovative Grafting (Osteotech). To help fill tough bone defects, surgeons may not need to look any further than a new bone graft implant, the Plexur M.

   Michael Downey, DPM, FACFAS, notes that Plexur M is a osteoconductive bone graft composite composed of bioresorbable polymer and cortical bone fibers. Dr. Downey says Plexur M is innovative in that it is the only composite bone graft substitute that is moldable, settable, machinable, radioopaque and completely remodels into new host bone.

   Dr. Downey has used the Plexur M for about a year for filling irregular osseous defects. For example, he notes the graft is “ideally suited” to fill defects that result from the evacuation of an aneurysmal or unicameral bone cyst from the calcaneus.

   Osteotech, the manufacturer of the product, says Plexur M provides surgeons with the ability to mold the graft to fit irregularly shaped defects and restore normal anatomy. The prepared Plexur M starts off as soft, moldable putty but hardens very quickly, according to Dr. Downey, the Chief of the Division of Podiatric Surgery at Penn Presbyterian Medical Center in Philadelphia.

   Once the product hardens, he notes the composite graft is quite strong and maintains its shape very well. He says surgeons can drill the Plexur M and it is strong enough to hold a fixation screw. As healing occurs, Dr. Downey says the Plexur M gradually incorporates and new host bone replaces the product.

   As for disadvantages, Dr. Downey says Plexur M should not be substantially considered an osteoinductive or osteogenic bone graft substitute. Therefore, he notes it is not his typical first choice for repair of a non-union.

   10. Stem cell allografts. Allografts composed of stem cells are emerging as a viable technology. Stem cell allografts differ from traditional allograft as they have living mesenchymal stem cells, according to Dr. Hyer. He says the mesenchymal stem cells allow the graft to provide osteogenic, osteoinductive and osteoconductive components whereas traditional allograft usually only have osteoconduction. Dr. Hyer has been using stem cell allografts for about two years.

    “This stem cell allograft is a true competitor to autograft harvested from the patient,” posits Dr. Hyer. “Autograft has long been considered the ‘gold standard’ but has negatives of limited quantity and the morbidity associated with second surgical site including pain, possible infection, etc.”

   Dr. Hyer notes that stem cell allografts are more expensive than simple allografts but typically cheaper than recombinant human bone morphogenetic protein (rh-BMP) products. He notes that the stem cells must be stored in a freezer at -70º C.