Every year brings new advances in the podiatric profession as technologies and modalities emerge to help DPMs overcome existing clinical hurdles. This year’s crop of innovations include the possible use of marrow-derived stem cells to facilitate wound healing, a new topical agent to help treat eczematous dermatoses and fixation devices that podiatric surgeons may find useful.
Without further delay, here is what the experts had to say on the top innovations in the podiatric profession.
1. Telbermin (Genentech). Diabetic foot ulcers are a persistent challenge. However, a new recombinant human vascular endothelial growth factor (rhVEGF) in the pipeline has demonstrated efficacy in treating such ulcers.
Telbermin has already undergone a phase I randomized, double-blind, placebo-controlled trial for the treatment of diabetic foot ulcers. Researchers evaluated 55 patients with 29 receiving telbermin and the rest of the patients receiving a placebo. Patients received telbermin up to three times a week for up to six weeks along with good wound care, according to an abstract presented at the Symposium on Advanced Wound Care.
In the telbermin group, 41.4 percent of the patients achieved complete healing in six weeks in comparison to 29.6 percent of placebo patients who achieved complete healing in six weeks, according to the study. Researchers also say the average time it took to achieve complete healing was 87 percent faster for patients in the telbermin group. The abstract authors conclude that telbermin has potential in treating diabetic foot ulcers although further studies are necessary.
David G. Armstrong, DPM, says telbermin likely has “a novel mode of action that can stimulate angiogenesis in a way that few other cytokines can.” While more research is needed, Dr. Armstrong says telbermin has promise.
“A new cytokine, particularly one as critical to the wound healing process as VEGF, is welcome in this area,” says Dr. Armstrong, a Professor of Surgery, Chair of Research and Assistant Dean at the William M. Scholl College of Podiatric Medicine at the Rosalind Franklin University of Medicine in Chicago.
Can These Biologic Scaffolds Facilitate Improved Surgical Outcomes?
2. OsteoCure™ Wedges (Nexa Orthopedics). An innovative resorbable scaffold may enhance bone growth. OsteoCure Wedges are porous and utilize PolyGraft® material technology, according to the manufacturer Nexa Orthopedics. The company adds that the scaffolds are made of polylactide-co-glycolide (PLG) copolymer, which facilitates structure and calcium sulfate for the enhancement of bone growth.
In addition, the company says polyglycolide (PGA) fibers add strength and surfactant permits the easy absorption of fluids into the scaffolds. The porous scaffold has a mean pore size of 500 to 600 µm and has 75 percent total porosity for tissue ingrowth. The architecture of the scaffold mimics natural bone, according to Nexa.
Nexa notes that the copolymer is amorphous (noncrystalline) and resorbs in four to eight months. The company says the hydrophilic properties of the wedges absorb blood, marrow, cells and proteins.
Patrick DeHeer, DPM, says OsteoCure Wedges work well. In the last two or three years, Dr. DeHeer has used them for pediatric surgery, including the Cotton osteotomy for pediatric flatfoot.
How do the wedges compare to other modalities? Dr. DeHeer, a Fellow of the American College of Foot and Ankle Surgeons, notes they are pre-cut in specific sizes and wedge shapes. The sizers and templates make usage “much easier intraoperatively,” explains Dr. DeHeer, a Diplomate of the American Board of Podiatric Surgery.
3. OrthAdapt™ Bioimplant (Pegasus Biologics). Another biological scaffold, the OrthAdapt Bioimplant, allows DPMs to repair and reinforce soft tissues such as tendons and ligaments, according to the manufacturer Pegasus Biologics.
The company says the product is indicated for the repair, reconstruction, augmentation and reinforcement of soft tissue in many orthopedic, sports medicine and foot and ankle procedures.
In addition, the company cites clinical results showing that the OrthAdapt Bioimplant does not produce any clinically significant inflammatory response and provides strength during the healing process for rapid, controlled remodeling at the site of the implant.
Lowell Weil Jr., DPM, has used OrthAdapt for the past 16 months and has found the implant to be beneficial for an array of applications.
“It has given me tremendous opportunities to enhance my surgery in peroneal tendon tears, posterior tibial tendon pathology, Achilles tendon reconstruction and lateral ankle instability/reconstruction,” says Dr. Weil, the Fellowship Director of the Weil Foot and Ankle Institute.
He adds that he has also used the implant recently to help treat difficult cases of hallux varus and MPJ dislocations.
Dr. Weil says the device is easy to handle and holds the suture well. OrthAdapt is strong yet thin so one can use it in small places in the foot, according to Dr. Weil. He adds that the product has a slow breakdown rate, which is important because this maintains the device’s strength and integrity to keep the desired position. Dr. Weil says the slow breakdown also means less swelling and inflammation. The collagen implant also resists premature enzymatic degradation, according to Pegasus.
Has The Time Arrived For Stem Cells In Wound Care?
4. Marrow-derived stem cells. The potential for the medical use of stem cells has been debated frequently in recent years. Can marrow-derived stem cells (MDSC) speed wound healing? An abstract recently presented at the American College of Foot and Ankle Surgeons Annual Scientific Meeting shows some positive results.
The abstract was a retrospective review of three patients who received autologous marrow-derived stem cells (MDSC). Bone MDSCs are multipotent cells capable of differentiations into multiple cell types, including cartilage, bone, brain, fibroblasts and keratinocytes, according to the abstract authors. They say the cells secrete large amounts of growth factors and cytokines, and have the potential to accelerate granulation tissue, healing and wound bed preparation.
The first patient had an open transmetatarsal amputation wound as well as neuropathy and HIV. The patient achieved 100 percent granulation tissue in 13 days following MDSC application, received a skin graft in 29 days post-MDSC and achieved complete healing in 60 days, according to the abstract.
The second patient, who had a venous leg ulcer, achieved 100 percent granulation tissue in 19 days. The abstract says the patient received a split-thickness skin graft in 31 days and achieved complete healing in 50 days.
The third patient, who suffered from diabetic neuropathic ulcers, achieved complete healing of dorsal toe ulcers with exposed bone and joint in 47 days, according to the study.
“Marrow-derived (adult) mesenchymal stem cells have great potential to improve the rate and quality of healing in a number of tissue types,” maintains Dr. Armstrong.
He adds that the Center for Lower Extremity Research (CLEAR) and the laboratory of Professor Daniel Peterson will be studying these stem cells in the first clinical project of Rosalind Franklin University’s Institute for Regeneration.
“I see many of the primary initial applications involving skin, the vasculature and bone,” adds Dr. Armstrong, the Director of CLEAR.
As Dr. Armstrong notes, the cells are pluripotent and therefore will transform into what they need to be to assist in regeneration.
While the process currently involves a marrow biopsy, Dr. Armstrong says researchers, in the future, hope to eventually harvest stem cells through a blood draw (to secure epidermal precursor cells) or through an even less invasive manner.
Modality Offers Benefits Of Negative Pressure Wound Therapy
5. Invia™ (Medela). Another device that may enhance wound healing is a recently developed product that combines negative pressure technology with antimicrobial dressings.
The Invia system is indicated for diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds, dehisced wounds, partial-thickness burns, flaps and grafts, according to the manufacturer Medela. The product consists of a low vacuum aspirator, specialty dressing kit and disposable canister as well as an antimicrobial Kerlix™ gauze to fluff into the wound bed.
Invia has a non-adherent wound contact layer that does not stick to the wound site or damage tissue during dressing changes. The company says this ensures that granulation tissue remains intact. The wound drain is a 100 percent silicone drain that Medela says is easy to cut and can be replaced simply in a wound.
Eric Travis, DPM, notes that the Invia Negative Pressure Wound System is meant to be a negative pressure system with antimicrobial properties, one that uses a more traditional dressing model to treat wounds. He has used the product on toe wounds and some “highly contaminated wounds that require more attention.” Dr. Travis notes that nurses and practitioners seem to use the system to treat discharge and accelerate granulation. He adds that it seems to be easier for nurses to monitor with every day dressing changes.
“My experience has been positive,” says Dr. Travis, who practices at Beach Podiatry in California. “It is not as intimidating as other negative pressure therapies. It is easy to apply and does not need a perfect seal.”
Dr. Travis cites Invia’s easy application and compliance with the basic principles of wound care. He says the silicone tubing is easy to use and the system offers suction variability that permits the management of pain and exudate. The system’s antimicrobial dressing permits direct contact to the wound surface and has the advantages of negative pressure therapy.
In terms of drawbacks, Dr. Travis notes that Invia is not as universally adaptable as other systems and says the suction tubing and dressing with Invia are less adaptable with heavily exudative wounds. He adds that the foam dressing with Vacuum Assisted Closure therapy (VAC Therapy, KCI) seems to handle the drainage with more efficiency and efficacy.
Can A New Topical Option Help Treat Dermatological Conditions?
6. MimyX™ (Stiefel Laboratories). For patients with lower extremity dermatitis, a new class of topical treatment may offer some relief.
MimyX is indicated for various types of dermatoses, including atopic dermatitis and allergic contact dermatitis, according to the manufacturer Stiefel Laboratories. The company says the product can relieve burning and itching as well as maintain a moist wound environment.
G. “Dock” Dockery, DPM, notes that MimyX Cream is a new class of topical therapy for atopic dermatitis and other eczematous dermatoses. It is non-steroidal and is also not a topical calcineurin inhibitor (TCI) unlike tacrolimus (Protopic, Astellas Pharma) and pimecrolimus (Elidel, Novartis). As he notes, the cream restores the disrupted skin barrier of atopic dermatitis and eczema, and also reduces exposure to environmental triggers of these conditions.
In addition, Dr. Dockery says MimyX replenishes deficient lipids such as PEA (an endogenous fatty acid that is deficient in eczematous skin), which modulates the skin immune response.
Overall, Dr. Dockery says MimyX is a significant addition to the armamentarium of treatment options for lower extremity dermatological conditions.
“This product meets a large void in the overall management of atopic and eczematous dermatitis between topical corticosteroids and topical calcineurin inhibitors, and can be used to maintain the skin after an acute episode,” maintains Dr. Dockery. “By reducing the overall signs and symptoms of erythema, severe pruritus, xerosis, lichenification, scaling and ultimately, excoriation of the skin in these cases, MimyX can greatly improve the quality of life in patients with chronic eczema and atopic dermatitis.”
Fixation Technologies You Should Know About
7. TightRope (Arthrex). Two new surgical innovations may provide surgeons success during procedures that involve fixation.
The TightRope is indicated for fixation of syndesmosis disruptions with associated ankle fractures, according to the manufacturer Arthrex. The company says the low-profile product has a #5 FiberWire loop that is tensioned and secured between metallic buttons that are placed against the outer cortices of the tibia and fibula. The TightRope provides physiologic stabilization of the ankle mortise, adds Arthrex.
Luke Cicchinelli, DPM, calls the TightRope an “exciting new osteotomy sparing option” for the correction of hallux abductovalgus (HAV). He says this modality allows one to address HAV as an articular deformity as opposed to an osseous deformity.
He notes that proper distal placement of the Mini-TightRope is important to prevent recurrent opening of the intermetatarsal angle.
One key advantage of the TightRope is that an osteotomy is not required.
“Since most complications arise in my opinion from the act of cutting, fixating or healing of an osteotomy, this (modality) could be revolutionary,” says Dr. Cicchinelli, who practices at Eastern Carolina Foot and Ankle Specialists.
Dr. Cicchinelli, a faculty member of the Podiatry Institute, says long-term results (at least a minimum of six months) are needed to see if correction is lasting or if there is any recurrence. He notes two cases in which the intermetatarsal angle has reopened yet the clinical result is acceptable. Dr. Cicchinelli also notes that with the TightRope, one does not get the decompressive effect of an osteotomy and one should consider this preoperatively.
8. Locking Compression Plate System (Synthes). The Locking Compression Plate (LCP) System is part of a stainless steel and titanium plate and screw system that combines locking screw technology with conventional plating techniques, according to the manufacturer Synthes.
The company notes the Small Fragment LCP Plates are indicated for the fixation of fractures, osteotomies and nonunions of areas including the distal tibia and fibula, particularly in osteopenic bone. Synthes says one may also use these plates to fixate periprosthetic fractures, osteopenic bone, nonunions or malunions. Finally, LCP 4.5 mm T-Plates are indicated to buttress metaphyseal fractures of the medial tibial plateau and distal tibia. Synthes adds that these plates can also help fixate osteopenic bone, nonunions and malunions.
For the past six to nine months, Dr. DeHeer has used the locking plates for first MPJ fusion and calls them “fantastic.” He says the fixation is “very rigid” and the plates are smaller. He had previously used another type of non-locking Synthes plate with a 4.0 cortical screw. Surgeons are using locking plates increasingly in orthopedic surgery, according to Dr. DeHeer, who is in private practice with various offices in Indianapolis.
“One orthopedic surgeon I work with said that locking plates were the biggest advancement in orthopedic surgery in the past 10 years,” says Dr. DeHeer. “I think locking plates take all the best qualities of external fixation and convert them to internal fixation.”
Among the plate system’s features are a “combi hole,” which allows the surgeon to choose between conventional plating techniques, locked plating techniques or a combination of both, according to the company. The product’s threaded hole section for locking screws provides the ability to create fixed-angle constructs, according to Synthes. It adds that the limited contact plate design reduces plate-to-bone contact, thus limiting vascular trauma.
A New Option For Plantar Fibromatosis
9. Transdermal Verapamil (PD Labs). Can a new treatment salve the pain for patients with plantar fibromatosis? Interim study results for Transdermal Verapamil 15% Gel are promising.
Interim study results of patients who applied the gel revealed a 61.5 percent decrease in plantar fibroma size for patients at 90 days (13 fibromas) and 75 percent for patients at 180 days (eight fibromas). At 90 days, 55.7 percent of patients had experienced a pain decrease and at 180 days, 73.2 patients related a pain decrease, according to the study cited by the manufacturer PD Labs.
Robert Schulte, DPM, the study’s principal investigator, has been using Transdermal Verapamil for two years for plantar fibromas.
“It dramatically reduced their pain,” maintains Dr. Schulte, who cannot recall one patient who did not have reduced pain after using the gel.
Dr. Schulte says for most, the pain decreased in three months while the majority of his patients were pain-free in six months. As he notes, there are “no other good options” for plantar fibromas and the fact that Verapamil is topical is advantageous. He notes a potential disadvantage in that patients must apply it twice a day but he says most of his patients are not bothered by this requirement.
Can Electrotherapy Provide Significant Pain Relief?
10. VST Myo Dynamic™ Device (V-Care Health Systems). A four-channel electrotherapy system may be the next advance for relieving various types of pain and increasing circulation.
The VST Myo Dynamic Device is indicated for the management of peripheral neuropathy and plantar fasciitis, according to the manufacturer V-Care Health Systems. The company notes that the product increases circulation, eliminates edema, increases range of motion and provides immediate post-surgical stimulation.
As the company asserts, the VST’s unique wave technology “appears to overcome the natural inhibitory arc imposed by the body during injury or trauma,” which permits the recruitment of deep muscle tissue in the injured area without causing pain. Deep penetration leads to significantly increased blood flow derived from the unlocking of the capillary and lymph systems, says V-Care.
The company adds that the increased circulation causes “tremendous” movement of edema fluid, reducing swelling and pain, but also carries the nutrients that the injured tendon or nerve fiber uses to rebuild itself. The company says the technology provides quicker recovery time for soft tissue injuries.
Raymond Abdo, DPM, has been using the VST device since January. He has primarily been using it to treat diabetic neuropathy as well as post-op pain and edema.
“I have had excellent results clinically with the machine in the office,” points out Dr. Abdo.
For related articles, see “A Guide To Emerging Advances In Diabetic Foot Ulcer Healing,” in the August 2007 issue, “What You Should Know About Atopic Dermatitis” in the September 2005 issue and “Emerging Innovations In Treatment” in the August 2006 issue of Podiatry Today.
Also be sure to visit the archives at www.podiatrytoday.com.