Top Innovations In Podiatric Care
Our annual roundup of innovations offers a closer look at an emerging ex-fix device, a laser that might be helpful in treating onychomycosis, and a variety of modalities that may facilitate optimal outcomes in wound care. For these bright ideas and more, this author talks to a variety of podiatrists about their experience with these products and their potential impact.
As technology advances, podiatrists have even more options in their armamentarium to help facilitate optimal outcomes. This year’s list of emerging innovations include a novel option for hammertoe surgery, two new negative pressure wound therapy devices and a new onychomycosis treatment. With that said, here is what the experts had to say.
1. Smart Toe (Memometal (MMI)). When surgeons remove K-wires after hammertoe surgery, maintaining correction may prove to be challenging and often deformities reoccur months to years later, frustrating patients and surgeons. Jason R. Miller, DPM, has seen many patients who presented after undergoing traditional arthroplasties or arthrodesis procedures with pin fixation that failed to maintain the desired correction.
“Patients would emphatically express their dissatisfaction with the pins and ask if any new alternatives were available,” he recalls.
Dr. Miller will offer such patients the Smart Toe, noting that it is the first implant that utilizes Nitinol technology to fixate a digital arthrodesis site permanently. He says the implant has solved “many, if not all” failure and implantation problems with the previous generations of in-dwelling implants.
“The design is well thought out as it readily grasps the bone from within and expands after exposure to body heat to secure the digit in the surgeon’s choice of positioning,” says Dr. Miller, a Fellow of the American College of Foot and Ankle Surgeons.
The Smart Toe is available as a neutral or angled implant, according to MMI. It says the one-piece implants do not require connection. The company adds that there is no post-op implant exposure and no disruption of healthy joints.
Dr. Miller has used the Smart Toe for close to a year and says it “prevents all the issues associated with external pin fixation,” such as lost pin caps, pin infections and patient adherence dilemmas. He says there are instances (prior history of infection, MPJ contractures, etc.) in which traditional pin fixation is superior.
“In general, however, the Smart Toe form of fixation offers a persistent internal beam, which maintains the correction even in instances in which complete arthrodesis has not been achieved,” explains Dr. Miller, who is in private practice at the Pennsylvania Orthopaedic Center in Malvern, Pa.
Inside Insights On A New Plantar Fasciitis Treatment
2. NeuroTherm NT250 RF Generator (NeuroTherm). For plantar fasciitis patients who do not respond to conservative treatment, a new advance in radiofrequency nerve ablation (RFNA) may provide relief.
NeuroTherm says the NT250 RF Generator can treat inferior heel pain and neuritis, and one can use the device in an in-office setting. The company notes the device can reduce heel pain by using radiofrequency nerve ablation to interfere with the pain signal. NeuroTherm cites a 92 percent success rate with RFNA therapy in achieving complete relief of pain from plantar fasciitis.
Doug Richie Jr., DPM, has used the NeuroTherm device on about 50 patients. As he notes, the NT250 RF is the first device that selectively isolates the nerve that transmits pain from the planar fascia.
The closest comparative treatment to the RFNA device would be cryosurgery, which also attempts to ablate the inferior calcaneal nerve that causes plantar heel pain, notes Dr. Richie, an Adjunct Associate Professor in the Department of Applied Biomechanics at the California School of Podiatric Medicine at Samuel Merritt University.
However, he notes a crucial difference between the two technologies. Whereas the NeuroTherm device isolates and ablates only the sensory fibers of the inferior calcaneal nerve, Dr. Richie says cryosurgery destroys both the sensory and motor fibers of the nerve. With cryosurgery, the motor fibers innervate the abductor digiti quinti brevis as well as the flexor digitorum brevis muscles. Dr. Richie notes both muscles are critical to the stability of the lesser toes and instability. He adds that hammertoe formation can result from a loss of function of these two important muscles.
Dr. Richie, who has spoken on behalf of the company at conferences, says several retrospective studies have been published regarding nerve ablation. While there is an absence of published randomized prospective trials, he notes that one is underway.
Can Two New NPWT Products Enhance Wound Healing?
3. VAC® GranuFoam™ Bridge Dressing (Kinetic Concepts (KCI)). Negative pressure wound therapy (NPWT) continues to attain good healing results. Now a new device may further accelerate wound healing with NPWT and offer adequate offloading at the same time.
With the GranuFoam Bridge Dressing, one can help facilitate the healing of diabetic foot wounds while offloading them, according to the manufacturer KCI. The company notes that the dressing has a wicking layer to keep skin dry and its components have a simple design for an easy dressing application. GranuFoam Bridge Dressing allows patients to resume mobility and permits them to transition back to non-acute care settings.
Sulman Bhutta, DPM, has used the GranuFoam Bridge Dressing for about two months. He cites the low profile of the dressing and the fact that one can use it in combination with an offloading device.
Raymond Abdo, DPM, who has utilized the GranuFoam Bridge Dressing for six months, says it facilitates granulation tissue in different wounds of the same foot without maceration, which was present in the past.
Dr. Abdo also notes that the dressing aids in allowing “excellent” promotion of new tissue on the plantar aspects of the feet.
“This is helpful even in patients who are unable to be non-weightbearing but still are ambulating in total contact casts,” says Dr. Abdo, who is in private practice at St. Louis Foot and Ankle in St. Louis.
As Dr. Bhutta notes, the GranuFoam Bridge drape has perforations that one can tear by hand to the appropriate size rather than having to cut the drape with scissors. He also says the pre-cut circular foam pieces are beneficial for applying to plantar foot ulcerations.
“I have had patients who have had difficulty applying the standard foam dressing and are now very pleased with the ease in applying the GranuFoam Bridge Dressing,” says Dr. Bhutta, who is in private practice at Allied Foot and Ankle in Westminster, Md. “Most of all, patients like the significant reduction in time required to apply the dressing.”
Dr. Abdo says the dressing also works well with products such as Dermagraft (Advanced Biohealing) or GraftJacket (Wright Medical).
4. Renasys Go/Renasys EZ (Smith and Nephew). At times, NPWT devices may seem bulky and intimidating to patients. The emergence of the new Renasys Go and Renasys EZ devices reportedly offer more portability and may subsequently increase patient adherence.
Both the Renasys Go and Renasys EZ are indicated for patients with pressure ulcers, diabetic ulcers, and skin grafts and flaps, according to the manufacturer Smith and Nephew. The company adds that one can also use the systems to treat subacute wounds and wound dehiscence as well as chronic, acute and traumatic wounds.
Edward Ferdinando, DPM, has used Renasys for a month within his armamentarium for treating diabetic foot ulcerations and, in certain circumstances, to help facilitate delayed wound closure. Dr. Ferdinando praises the safety features (such as the locking and alarm systems) of the devices and says they are easy to use.
“I like the fact that you can use both the sponge and gauze. This comes in handy in the hospital setting, where supplies may not always be available,” points out Dr. Ferdinando, the Director of Podiatric Residency Training at Staten Island University Hospital in Staten Island, N.Y.
In terms of potential drawbacks, Dr. Ferdinando says creating a good seal may be challenging and patient adherence could be an issue at times.
Smith and Nephew notes that the digital pressure settings of the Renasys Go (ranging from 40 to 200 mmHg) are user-friendly and decrease the chance of error. The company emphasizes that the lightweight device (2.4 lbs.) is quiet and comfortable, attributes that should increase patient adherence.
As for the Renasys EZ, the company says its intuitive design and quick-click connectors can reduce medical errors. The pressure settings for this device also range between 40 and 200 mmHg. Smith and Nephew notes the 7.4 lb. device comes with an intravenous pole and bed mount as well as an 800-cc canister.
Can An Emerging Gauze Product Sense The Moisture Needs Of Wounds?
5. TheraGauze (Soluble Systems). Dry wounds may become necrotic and wet wounds may develop infection. Having an appropriate level of moisture is key in healing wounds. One emerging gauze product may be able to provide moisture or dryness according to the needs of the wound.
TheraGauze employs precise moisture regulation via Skin Moisture Rebalancing Technology (SMRT), which permits the gauze to differentially release or absorb moisture according to the wound’s underlying condition. The company notes that the product’s inert, breathable polymer chains form a vertical matrix surrounded by microscopic channels, allowing TheraGauze to control moisture at a cellular level.
Lawrence DiDomenico, DPM, says the SMRT polymer can sense and respond to different moisture needs in the same wound. He says it donates moisture to dry areas while simultaneously pulling away moisture from wet areas.
Soluble Systems says TheraGauze will not macerate or adhere to the wound or surrounding tissue. The company adds that the product causes no pain upon removal and leaves no residue. Soluble Systems notes that the gauze can remain active and moist for up to a week.
Dr. DiDomenico has been using the product since 2008. He notes that DPMs can use it to treat a variety of wounds including diabetic foot ulcers, venous stasis ulcers, pressure ulcers, burns and skin tears. One can also employ TheraGauze in combination with split thickness skin grafts and complex skin flaps, according to Dr. DiDomenico, the Director of the Reconstructive Rearfoot and Ankle Surgical Fellowship within the Ankle and Foot Care Centers and the Ohio College of Podiatric Medicine.
The fact that TheraGauze can release or absorb moisture based on the underlying molecular condition of the wound makes the product the best choice in terms of dressings to treat complex wounds, according to Dr. DiDomenico, a Fellow of the American College of Foot and Ankle Surgeons.
He notes that ordinary wound dressings address a single moisture condition. One may use absorbent materials or gauze on a wet, exudating wound whereas wet dressings such as hydrogels are effective on a dry wound. However, Dr. DiDomenico notes that complex wounds often contain areas of both excess moisture and dry tissue, and TheraGauze controls moisture at the wound interface.
“From a patient’s perspective, there is no alternative to TheraGauze,” maintains Dr. DiDomenico.
Can A Laser Provide Effective Onychomycosis Treatment?
6. Noveon® (Nomir Medical Technologies). “With all of the current antifungal drugs, both topical and oral, having gone generic and a number of notable failures being reported in new drug development, medical device companies are developing innovative ways to treat onychomycosis,” notes Warren Joseph, DPM.
One such innovation is the Noveon laser (Nomir Medical Technologies), says Dr. Joseph. Unlike high-powered lasers that create a “thermal or ablative killing” of fungal and bacterial cells, the Noveon employs two discrete near-infrared wavelengths (870 nm and 930 nm) to kill the organisms, according to Dr. Joseph. He points out that the Noveon laser uses a photo-inactivation effect, which occurs at energy levels and temperatures that are low enough to preserve healthy tissue. As Dr. Joseph notes, this effect is not present in ablative lasers such as the Nd:YAG or ultraviolet devices currently under investigation.
Nomir Medical Technologies notes that the Noveon laser has demonstrated in trials that it is efficacious in treating onychomycosis without any thermal effects. One trial showed that 76 percent of toes showed improvement of onychomycosis and 74 percent of toes demonstrated a significant decrease in positive cultures after two treatments with the Noveon laser, according to the company.
Dr. Joseph says the company has completed an IRB approved pivotal trial and submitted this to the Food and Drug Administration (FDA) to obtain a specific indication for treating onychomycosis. If the FDA grants approval, the Noveon laser will be the first device to have achieved this specific level of FDA clearance, points out Dr. Joseph, who is affiliated with the Roxborough Memorial Hospital in Philadelphia and the Coatesville Veterans Affairs Medical Center in Coatesville, Pa.
The FDA has previously approved Noveon for use in contact and non-contact surgical procedures of the skin, subcutaneous tissues, and nasal passages in dermatology, podiatry, plastic surgery and otolaryngology.
Nomir Medical Technologies also cites pilot studies looking at the ability of the Noveon laser to eliminate methicillin-resistant Staphylococcus aureus (MRSA) in the nose.
“Although more studies need to be undertaken, this selective photo-damage effect against prokaryotic and fungal pathogens may eventually prove useful in the management of lower extremity bacterial infections,” says Dr. Joseph, a consultant to Nomir Medical Technologies.
The company says the laser uses optical energy to eliminate biofilm, bacteria and fungi and facilitate the recovery of tissue with fewer side effects than with pharmaceutical treatments. Nomir Medical Technologies notes that the laser is gentle due to its photobiologic mechanism of action, which does not produce heat.
Pertinent Pearls On A New Pediatric Orthosis
7. P3 Kiddythotic (ProLab Orthotics). With the P3 Kiddythotic, podiatrists can determine orthotic sizes themselves rather than relying on a lab.
Ronald Valmassy, DPM, has been using the device and feels it is “the best of any of the prefabricated devices” that he has ever used. He notes the orthosis can control mild to moderate abnormal foot pronation in pediatric patients.
“The fact that the laboratory provides sizing devices for in-office use makes it quite easy from a practical point to obtain the proper size for the youngster’s foot,” says Dr. Valmassy, who practices at the Center for Sports Medicine at St. Francis Memorial Hospital in San Francisco.
Dr. Valmassy says the P3 Kiddythotic allows DPMs to demonstrate to the child’s parents how the orthosis will function. In addition, the child can stand on the device so the podiatrist can determine which changes the child’s foot may go through and plan accordingly for future orthotic sizes.
ProLab Orthotics says the P3 Kiddythotic can help treat young children with pediatric flexible flatfoot. The company notes that the P3 Kiddythotic is the only functional prefabricated orthotic that offers a rigid polypropylene shell, medial flange, deep heel cup, a 4-mm medial heel skive and 4/4 rearfoot post.
With the P3 device, Dr. Valmassy notes that he can increase correction by adding forefoot or rearfoot posting. He usually adds the posting via ¼-inch or 1/8-inch Korex. Dr. Valmassy says he can increase the correction by 2 to 5 degrees, making the P3 a customized device without incurring the cost of an actual customized device.
When it comes to patients with a severe pes planus foot deformity or a residual talipes calcaneal valgus deformity, Dr. Valmassy says prefab orthoses are not aggressive enough to decrease abnormal pronation. For these patients, he will cast the patient for an UCBL device or a functional inverted orthosis that will provide better control of forefoot subluxation.
What You Should Know About A New Ex-Fix Device
8. Hoffman II MRI External Fixation System (Stryker Orthopaedics). When utilizing flaps and grafts in high-risk patients, David Armstrong, DPM, PhD, says there is a need to keep the flaps and grafts stable and free from micromotion. This has led him to use external fixation devices such as the Hoffman II MRI External Fixation System. He notes one can modify these devices when the patient is no longer confined to a bed or a chair. Dr. Armstrong and his colleagues have developed a construct of the device that is now termed the “SALSAstand.”
Stryker Orthopaedics says this external fixation system concentrates on two key areas that are of concern in MRI use: frame displacement due to magnetic (mechanical) forces and frame heating due to induced electrical currents (thermal forces). To combat the displacement due to magnetic forces, the company notes the ex-fix system is composed of materials that are nonferromagnetic and nonconductive. In addition, with the Hoffman II MRI External Fixation System, Stryker Orthopaedics says surgeons can build various types of frame constructions without any additional risk to patients in an MRI environment of up to 3.0 Tesla.
On a recent blog for Podiatry Today, Dr. Armstrong notes a technique in which he used the Hoffman II fixation system in a patient who had end-stage renal disease and a gangrenous forefoot. (See www.podiatrytoday.com/blogged/modified-salsa-goalpost-fixationoffloadin…). Using Achilles tendon lengthening and external fixation, he was able to correct the patient’s equinovarus position.
“We believe this aggressive stabilization and protection of the rotational flap may be helpful in these very compromised patients,” says Dr. Armstrong, a Professor of Surgery and Director of the Southern Arizona Limb Salvage Alliance (SALSA) at the University of Arizona College of Medicine. He frequently uses this technique as an adjunctive aid at SALSA.
Getting A Clearer Picture Of Wounds
9. SilhouetteMobile Camera (Aranz Medical). Since DPMs understand how important accurate measurements are in documenting wound progress, it can be invaluable to have a camera that captures information about the wounds from every angle without having to touch the wound like other planimetric measuring devices.
Aranz Medical notes that one can use the non-contact SilhouetteMobile camera to capture information about the patient’s wound at the bedside, analyze the data and store it on a database. The camera can store photos, wound measurements and other wound assessment data, according to the company. The SilhouetteMobile uses SmartCalibration technology, which the company says is based on SilhouetteCamera, a high-resolution digital camera attached to a PDA with custom software.
Lee C. Rogers, DPM, has used the SilhouetteMobile for over a year and has four cameras, which can all communicate to a central database via SilhouetteCentral software. He is also using the SilhouetteMobile for several of his research studies since the camera can accurately track wound progression.
Dr. Rogers has completed a study, which he submitted to the American Podiatric Medical Association (APMA) Annual Scientific Conference, which compared SilhouetteMobile wound area measurement with manual calculation of wound area (length x width). The study found that manual measurement grossly overestimates wound area.
Aranz Medical notes that the camera can capture two images of the wound, one image of the wound area and one of depth or height. Then the physician can define the wound boundary by drawing around the wound outline with a stylus on the PDA screen. The SilhouetteMobile creates a 3-D model of the wound surface and the computer “unwraps” the surface when calculating the true area, notes Dr. Rogers, the Director of the Amputation Prevention Center at Broadlawns Medical Center in Des Moines, Iowa.
The SilhouetteMobile automatically graphs the wound healing progression over time and produces reports on wound measurement, according to Aranz Medical. Dr. Rogers says this information is helpful in determining whether the prescribed treatment is working.
A Novel Solution For Chronic Wounds?
10. Pimecrolimus cream (Elidel, Novartis). When it comes to inflammation with chronic foot and ankle wounds, one may want to investigate an off-label solution.
While Elidel is currently indicated for mild to moderate eczema in adults and children over 2, Dr. Armstrong says using such anti-inflammatory/immune modulators on an off-label basis may help with chronically inflamed lower extremity wounds.
Dr. Armstrong says pimecrolimus shows potential in reducing “the often deleterious cycle of chronic inflammation that thwarts efforts at healing some wounds once the infection and vascular issues have been ruled out or are under some control.”
