Could emerging amniotic matrices facilitate improved wound healing? Could a new device help provide relief for patients suffering from plantar fasciitis? Does a new viscoelastic implant offer promise in the treatment of hallux limitus? With these questions in mind, this author talks to leading podiatrists to get their perspective on the latest innovations in the field.
This year’s new innovations include technological advances that may heal wounds faster, an intriguing implant for hallux limitus, an early warning device for detecting diabetic foot ulcers, new placental matrices for wounds and a product that may bolster adherence to home exercises for patients with plantar fasciitis. Here is what the experts had to say.
Cartiva Synthetic Cartilage Implant (Cartiva). Surgeons in the United States will soon be able to take advantage of a new cartilage implant for hallux limitus.
The Cartiva Synthetic Cartilage Implant garnered premarket approval by the Food and Drug Administration (FDA) in April for the treatment of degenerative or posttraumatic arthritis in the first metatarsophalangeal joint (MPJ) along with hallux valgus or hallux limitus.
Bob Baravarian, DPM, recently started using the implant and cites “amazing” results with Cartiva in Europe. The device is ideal for stages 2 and 3 hallux limitus, but Dr. Baravarian cautions against using it for end-stage hallux limitus.
Dr. Baravarian, an Assistant Clinical Professor at the UCLA School of Medicine, notes Cartiva requires no bone cuts or shortening. He says one places the viscoelastic implant in a slot hole, which acts as a spacer in the joint.
The Cartiva Synthetic Cartilage Implant is an organic polymer-based biomaterial comprised of 40% polyvinyl alcohol (PVA) and 0.9% saline, according to the manufacturer Cartiva. The company notes one can customize the physical, chemical and mechanical properties of PVA to defined functional requirements. Cartiva says the viscoelastic implant can withstand the repetitive loading of the first metatarsophalangeal joint.
Cartiva adds that the implant carries no risk of transmitting bacteria, does not degrade and causes no systemic irritation. The company says the synthetic cartilage has properties similar to native cartilage and its low coefficient of friction can support joint articulation and mobility.
Omnigraft Dermal Regeneration Matrix has a silicone layer that immediately protects the wound and that one removes after 14 to 21 days, according to the manufacturer Integra LifeSciences. The company notes that the dermal replacement layer, consisting of collagen/chondroitin-6-sulfate, is a bioengineered scaffold that promotes dermal regeneration. The company notes Omnigraft is indicated for partial- and full-thickness diabetic neuropathic ulcerations that have been present for more than six weeks with no exposed capsule, tendon or bone.
Paul Kim, DPM, MS, FACFAS, says Omnigraft was the subject of the largest multicenter randomized controlled trial to date on diabetic foot ulcers.1 In the study, researchers evaluated the treatment of 307 patients with at least one diabetic foot ulcer. The authors noted the median time to complete DFU closure was 43 days for Omnigraft patients in comparison to 78 days for control patients.
Dr. Kim, an Associate Professor and the Director of Research for the Department of Plastic Surgery at the Georgetown University School of Medicine, notes that Omnigraft is similar to the Integra Bilayer Matrix Wound Dressing, which he has used in the operating room for 10 years. With the advent of Omnigraft, he says physicians can now use an OR-based product in the clinic. Dr. Kim suggests utilizing Omnigraft in wounds with limited bacterial bioburden and adequate perfusion, and in combination with appropriate surgical or conservative offloading.
The SonicOne O.R. with SonicVac reduces spray dispersion, captures fluids and used irrigate from the wound, and also removes debris from the operating field, according to the manufacturer Misonix.
Peter Blume, DPM, FACFAS, notes the innovation with this type of ultrasound technology is that it allows for cavitation with removal of devitalized tissue without impacting the surrounding healthy tissue. He also cites the device’s abilities to facilitate biofilm removal. SonicVac provides controlled debridement at a depth that one can determine easily with the product’s vacuum aspiration.
Dr. Blume, an Assistant Clinical Professor of Surgery in the Department of Surgery at the Yale University School of Medicine, has been using the new SonicVac for a few months and cites “excellent success.” He has submitted a poster to the Diabetic Limb Salvage conference that demonstrates an increased skin graft take with the use of Misonix debridement instrumentation.
V.A.C. VeraFlo (KCI). Can instillation therapy bolster the effect of a tried and true negative pressure wound therapy (NPWT) device?
The V.A.C. VeraFlo is the most efficient modality for surgeons to use between surgical excisional debridements to prepare the wound for staged closure or coverage, according to Dr. Kim. In addition to facilitating cleansing of the wound in a consistent, controlled manner, using the V.A.C. VeraFlo enables one to address infectious materials in the wound through the instillation of antimicrobials and antiseptics, according to the manufacturer KCI. The company notes that in a porcine study, subjects using V.A.C. VeraFlo had 43 percent more granulation tissue than those receiving standard NPWT.2
In comparison to other products, the V.A.C. VeraFlo facilitates faster wound bed preparation for closure or coverage in patients presenting with infected wounds, according to Dr. Kim.
“There is no other current modality that is able to do this,” adds Dr. Kim.
He points out that the use of V.A.C. VeraFlo has facilitated a decreased hospital length of stay as well as a decreased number of surgeries. Dr. Kim says the product is limited to use in the hospital or acute rehab facilities, and is not for home use.
A Closer Look At Emerging Placental Tissue Matrices
AmnioBand (Musculoskeletal Transplant Foundation). An emerging allograft placental matrix continues to demonstrate the value of placental tissue in healing lower extremity wounds.
AmnioBand is indicated for acute and chronic wounds, specifically diabetic foot ulcers, venous ulcers, pressure ulcers and vascular ulcers, according to the non-profit manufacturer Musculoskeletal Transplant Foundation. The company notes the dehydrated amnion/chorion human membrane can help restore and remodel native tissue, and has flexible properties to help it conform to the wound. The Musculoskeletal Transplant Foundation adds that AmnioBand prevents infection and bacteria infiltration, supplies matrix proteins, and spurs tissue epithelialization.
Lawrence DiDomenico, DPM, FACFAS, cites a study noting that AmnioBand had a wound healing effect that was statistically significantly higher than standard of care alone at six weeks and 12 weeks.3 He notes AmnioBand also has a lower cost to closure. The company notes that the matrix’s aseptic processing preserves the natural structure of the graft and is directly compatible with the host extracellular matrix.
“There is a tremendous value in aseptic processing,” notes Dr. DiDiomenico, the Section Chief of the Department of Podiatry at St. Elizabeth Hospital in Youngstown, Ohio.
Dr. DiDomenico also cites several other advantages of AmnioBand. He notes the product has a long shelf life and is ready to use as it doesn’t need to be frozen with subsequent thawing prior to use.
Interfyl (Alliqua Biomedical). Another purportedly promising placental graft is Interfyl, which was slated to hit the market in 2016 as this issue went to press.
Interfyl is a decellularized, dehydrated placental disc (chorionic plate)-derived extracellular matrix with a connective tissue matrix that is a scaffold for recipient cells in the wound to regenerate soft tissue, according to information that the product’s manufacturer Alliqua Biomedical provided to the Centers for Medicare and Medicaid Services (CMS).
Interfyl upregulates and downregulates inflammatory cells, stimulating the body to recruit its own growth factors to the area to allow for healing, notes Stephen Brigido, DPM, FACFAS.
Dr. Brigido has been involved with the premarket trial work for the product and calls Interfyl “incredible.” He notes Interfyl is the first and only flowable acellular placental graft on the market. Dr. Brigido adds that the graft comes in both a micronized injectable form and a particulate form that has the appearance of cotton candy.
The uses for Interfyl range from tendon and ligament augmentation to full thickness wound repair, according to Dr. Brigido, the Fellowship Director of Foot and Ankle Reconstruction at Coordinated Health in Bethlehem, Pa. Interfyl replaces or supplements damaged or inadequate integumental tissue by providing support for the body’s normal healing processes, according to the company.
Predicting Diabetic Foot Ulcers Before They Happen
Remote Temperature Monitoring System (Podimetrics). Predicting diabetic foot ulcers ahead of time may enable physicians to head off dire complications and a new temperature sensing mat may give them a head start.
As Lee C. Rogers, DPM, explains, before tissue breaks down and becomes an ulcer, it becomes inflamed. In sensate individuals, this inflammation would manifest as pain but in those with a loss of protective sensation, he says one must look for other signs of tissue damage. Dr. Rogers says the Remote Temperature Monitoring System is a mat that measures and uploads a patient’s foot temperatures. When the mat shows one location on the foot has divergent temperatures (a “hot spot”) in comparison to the same location on the contralateral foot, he says it is significant for inflammation and tissue damage, and is predictive of foot ulceration.4,5
The manufacturer Podimetrics notes the scans only take 20 seconds a day on the wireless mat and the company will analyze the data received. Dr. Rogers cites a study presented at various meetings (and submitted for publication) that assessed the use of the device in 130 high-risk patients with diabetes and a previous history of ulceration. The study showed that the device was able to predict ulcers more than 30 days before they occur.
“(The Podimetrics System) is an early warning system for the diabetic foot and has the potential, when combined with good podiatric care, to prevent thousands of ulcers and amputations, which could save the healthcare system billions of dollars,” says Dr. Rogers, the Medical Director of the Amputation Prevention Centers of America.6
Could A New Advance In Conservative Care Have An Impact For Plantar Fasciitis And Achilles Tendinitis?
Foot Gym Pro (Allied OSI Labs). Patients with plantar fasciitis or Achilles tendinitis may get relief from a new massage roller that provides hot or cold therapy.
Doug Richie Jr., DPM, FACFAS, calls the Foot Gym Pro the first “all in one” package of tools for rehabilitation of the foot and ankle. He notes the device offers therapy tools including hot/cold therapy and facilitates a total of nine exercises. The product is indicated for home therapy and treatment of plantar heel pain, posterior tibial tendon dysfunction or any weakness of the foot and ankle, says Dr. Richie, an Adjunct Associate Professor within the Department of Applied Biomechanics at the California School of Podiatric Medicine at Samuel Merritt University.
As Dr. Richie says, he often gives patients a number of stretching exercises for the Achilles and plantar fascia when treating plantar heel pain, and also provides strengthening exercises such as picking up marbles or doing toe curls. Furthermore, he will often recommend deep tissue massage as well as hot/cold therapy of the arch and heel when treating plantar heel pain.
“This device provides easy to use tools to accomplish all of these treatment goals in the home setting. A simple device like this would ensure completion of all the treatments because they are presented as a single package,” says Dr. Richie.
The device’s slant board facilitates dorsiflexion stretch on an antimicrobial pad made of ethylene vinyl acetate (EVA), according to the manufacturer Allied OSI. The company notes patients can use the Foot Gym Pro while sitting or standing, and its resistance bands provide light, medium or firm resistance.
With the Foot Gym Pro, Dr. Richie would expect much better patient adherence as patients do not have to hunt down and store all the marbles, rubber bands, tennis balls, frozen bottles and other devices that would otherwise be necessary for all the components of the home exercise program for the feet.
Although patients may have an initial reaction that this device looks “gimmicky,” after a brief review of all the exercises available and the alternative to doing these at home with their own marbles, rubber bands, frozen bottles and tennis balls, Dr. Richie says the advantage becomes apparent.
In order to increase the effectiveness of the Foot Gym Pro, Dr. Richie recommends stocking the product to facilitate easy demonstration and dispensing in the office setting. He concedes that some physicians are resistant to pre-ordering and stocking any devices for resale in the office. Dr. Richie also cautions that the device is not reimbursable by insurance and this can be a deterrent for some patients. However, Dr. Richie notes other physicians see the Foot Gym Pro as a valuable treatment tool with the potential to improve practice income.
Defending Against Infection And Muscle Fatigue
[pH]Uel 5.0 (Avadim Technologies). An emerging product reportedly works with the epidermis to impart a number of beneficial clinical effects.
The product [pH]Uel 5.0 lowers a patient’s pH and optimizes the stratum corneum, according to the product’s manufacturer Avadim Technologies. Nicholas Romansky, DPM, FACFAS, notes the product’s composition includes silver, grapefruit, aloe and allantoin.
The company says the product defends against bacterial infection, fungal infection and muscle fatigue. Dr. Romansky has used the product for about six months. He says [pH]Uel 5.0 offers skin healing and skin protection in patients with conditions such as plantar fasciitis, shin splints, muscle soreness or open wounds. He adds that it can stop infection and spur quick healing.
There are no side effects or contraindications with [pH]Uel 5.0 and it works well with other topical agents, according to Dr. Romansky, a Diplomate of the American Board of Podiatric Surgery, who is in private practice in Media and Phoenixville, Pa. He says patients can rub the product on their skin and get an immediate cooling effect. Dr. Romansky adds that patients can apply the product multiple times a day and the effect lasts for about five hours.
Relieving Lower Extremity Pain With Inserts
Arch Mobility Inserts (Protalus). Innovative inserts may help relieve the lower extremity of pain due to plantar fasciitis, ankle pain, pain on the ball of the foot and various other conditions.
Arch Mobility Inserts focus on creating a more neutral alignment of the foot, enhanced pronation control and improved cushioning, according to the manufacturer Protalus. The company notes that the inserts externally rotate the talus up to 27 percent into a subtalar neutral position and also externally rotate the tibia up to 40 percent into a subtalar neutral position, which Dr. Romansky says maximizes energy and makes the foot more aligned.
The improved biomechanical alignment within the kinetic chain facilitates less repetitive stresses and strains to joints, muscles, ligaments and tendons, according to Protalus.
Dr. Romansky says the Protalus Arch Mobility Insert is an OTC orthotic that is the closest in his experience to a custom orthosis to control the talonavicular joint. He notes the orthotic is effective for patients with hypermobility, flatfoot, shin splints, sinus tarsi syndrome and lateral ankle impingement.
The company says the product’s unique heel design and proprietary materials (such as thermoplastic polyurethane, acrylonitrile butadiene styrene, chitin and mesh A fabric) absorb and redistribute energy, and redistribute pressure in the foot, leading to more comfort and less stress.
- Driver VR, Lavery LA, Reyzelman AM, et al. A clinical trial of Integra Template for diabetic foot ulcer treatment. Wound Repair Regen. 2015; 23(6):891-900.
- Lessing MC, Slack P, Hong KZ, et al. Negative pressure wound therapy with controlled saline instillation (NPWTi): dressing properties and granulation response in vivo. Wounds. 2011;23(10):309-319.
- Zelen CM, Orgill DP, Serena T, et al. A prospective, randomised, controlled, multicentre clinical trial examining healing rates, safety and cost to closure of an acellular reticular allogenic human dermis versus standard of care in the treatment of chronic diabetic foot ulcers. Int Wound J. 2016; epub April 12.
- Lavery LA, Higgins KR, Lanctot DR, et al. Home monitoring of foot skin temperatures to prevent ulceration. Diabetes Care. 2004;27(11):2642-7.
- Lavery LA, Higgins KR, Lanctot DR, et al. Preventing diabetic foot ulcers recurrence in high-risk patients: use of temperature monitoring as a self-assessment tool. Diabetes Care. 2007;30(1):14-20.
- Rogers LC, Lavery LA, Armstrong DG. The right to bear legs—An amendment to healthcare: How preventing amputations can save billions for the U.S. Health-care System. J Am Podiatr Med Assoc. 2008;98(2):166-8.