BB&T Contributing Editor
LAS VEGAS, Nevada – The annual scientific meeting of the American Podiatric Medical Association (Bethesda, Maryland) was held here to an audience of about 4,000 attendees. Key areas of interest were diabetic foot ulcers, peripheral artery disease, plantar fasciitis, neuropathy and bone implants.
Dr. David Armstrong, professor of surgery at Dr. William M. Scholl College of Podiatric Medicine (North Chicago, Illinois), emphasized the need for diabetic patients to do moderate activity to toughen the skin under their feet to prevent ulcer formation. He advocated the use of a personal dermal thermometer to identify hot spots on the feet as means of foretelling ulcer formation. Armstrong described this skin temperature measurement as a “glucose meter for the foot.” It is the subject of three ongoing randomized clinical trials.
SAM Medical Products (Newport, Oregon) exhibited its Celox hemostat granules designed to control high-volume arterial bleeding as well as for superficial wounds. It is prepared from chitosan, a marine biopolymer that is obtained from the shells of crustaceans. A similar chitosan-based product that is marketed as a bandage is sold by HemCon (Portland, Oregon) for use in the military.
SAM Medical recently introduced its BursaMed adhesive bandage for the prevention and treatment of ulcerated wounds. It is a multi-layer polyethylene occlusive bandage with a gliding dome that is specifically designed to protect against erythema, diabetic ulcers and blisters by reducing shear and friction forces. The company is best known for its SAM Splint, a soft and moldable support.
Hyperbaric oxygen has been approved for Medicare reimbursement for over a dozen indications including diabetic wounds of the lower extremities. Companies that exhibited their single- and multiple-person hyperbaric chambers were OxyHeal Health Group (National City, California) and Perry Baromedical (Riviera Beach, Florida). They emphasized the service that accompanies their chambers such as product installation, staffing, training and management systems.
BioVisual Technologies (Westwood, New Jersey) featured its use of PictZar CDM digital planimetry software for accurate wound mapping. Footlogic (South Salem, New York) demonstrated its PressureStat method for measuring plantar pressure for quantifying high-pressure points in the foot that may be prone to wound development.
Tests for peripheral artery disease
Peripheral artery disease (PAD) is said to afflict 8 million to 10 million Americans and can lead to heart attack or stroke. It is a serious vascular complication that affects one in three diabetes patients. PAD has few symptoms and often goes undetected.
Because of the high cardiovascular risk associated with PAD and the potential for functional impairment and limb loss, a consensus panel brought together by the American Diabetes Association (Alexandria, Virginia) recommended that anyone over the age of 50 who has diabetes get screened for PAD. For diabetics under 50 years old, screening should be considered if there are other risk factors for this condition, such as smoking, high blood pressure, high cholesterol or having diabetes for more than 10 years.
The recommended test for PAD is the ankle brachial index, which compares the blood pressure in a person’s ankle to the blood pressure in their arm. If the blood pressure in the ankle is lower than in the arm, then the person may have PAD.
Biomedix (Saint Paul, Minnesota) displayed its PADnet Lab equipment that is used to test peripheral arteries for blockages and the quality of blood flow. Results of this 15- to 20-minute test are sent via the web for interpretation by a vascular specialist. The company has a co-marketing agreement with the Cordis (Warren, New Jersey) subsidiary of Johnson & Johnson (New Brunswick, New Jersey).
Koven Technology (St. Louis) markets the Smartdrop 45, a bi-directional recording Doppler ultrasound with LCD display for detecting arterial and venous blood flow in the extremities as an assessment of PAD. It displays and prints velocity waveforms and numerical data. Toe pressure and ankle brachial index are used to determine the small-vessel vascular condition distal to the ankle and for baseline diabetic foot assessment.
HyperMed (Waltham, Massachusetts) is developing Medical Hyperspectral Imaging (MHSI) as a medical imaging tissue assessment tool that can differentiate between healthy and diseased tissue and can deliver immediate information to physicians in the hospital and clinic, improving patient diagnosis and therapy. HyperMed’s technology is based on a technique originally developed by the U.S. Department of Defense to collect spectroscopic information from a remote target surface. By creating a 2-D image that has spectral data inherent in each pixel, hyperspectral imaging is able to provide information about the chemistry and thus clinical condition of a target area. The first application being targeted for this platform technology is for evaluating and diagnosing individuals with diabetic foot ulcers and PAD.
Plantar fasciitis, tendonitis, neuropathy
Maria Kasper, DPM, described the multiple uses of a cold laser in podiatry. These include the treatment of plantar fasciitis, tendonitis and diabetic neuropathy. She explained that laser light penetrates the cells and increases their metabolism, but normally functioning tissue is not affected. The laser light was said to stimulate healing of acute sprains and strains, and for damaged nerve tissue.
Heel pain can be caused by plantar fasciitis, heel spurs or heel pad atrophy. Plantar fasciitis occurs when the long, flat ligament along the bottom of the foot develops tears and inflammation. Serious cases of plantar fasciitis can possibly lead to ruptures in the plantar fascia ligament that extends to the five toes and runs along the bottom of the foot and is attached to the heel.
Orthotic supports are commonly used to relieve the pain from plantar fasciitis. Alternative therapies also were on display at the conference.
Biosyntech (Montreal) is developing BST-InPod, an injectable material for treatment of pain from heel pad atrophy. This condition is caused by thinning of the fat pad under the heel, which occurs with aging and from high-impact sports. The risk of atrophy increases with diabetes and from wearing high-heeled shoes.
Fabrifoam Products (Exton, Pennsylvania) markets the PSC (pronation spring control) strap that functions as a brace by providing compression support to alleviate pain from plantar fasciitis, heel spurs and tendonitis. The wrap simulates a corrective foot taping by supporting the plantar fascia of both cavus (high arched) and pronated (low-arched) foot types. Unlike taping, the PSC straps can be removed and reapplied.
Several companies featured extracorporeal shock wave therapy (ESWT) as a non-invasive outpatient procedure that is an alternative to surgery for the treatment of chronic plantar fasciitis.
SanuWave’s (Marietta, Georgia) OssaTron was the first ESWT system to receive FDA approval for orthopedic use, including the treatment of proximal plantar fasciitis. Orthometrix (White Plains, New York) markets the Orbasone ESWT pain relief system and recently formed Orbasone Mobile, a subsidiary that offers treatment in ambulatory surgery centers and physician’s offices.
Medispec (Germantown, Maryland and Yehud, Israel) exhibited its Orthospec ESWT device. EMS (Nyon, Switzerland/Dallas) displayed its DolorClast equipment that pneumatically delivers radial shock waves for treating plantar fasciitis, heel spurs and Achilles tendonitis. These companies also market their products for lithotripsy applications, for disintegrating kidney stones and gallstones.
United Shockwave Therapies (Northbrook, Illinois) is an ESWT service provider for 700 podiatrists and orthopedists.
Arthrocare (Sunnyvale, California) promoted its Topaz microdebridement procedure for the relief of pain from degenerative conditions of tendons and fascia, such as Achilles’ tendonitis and plantar fasciitis.
CryoTech (Acworth, Georgia) uses cryosurgical equipment with a hand-held probe to treat plantar fasciitis, Morton’s neuroma and peripheral nerve of the foot and ankle. Its principal markets are podiatrists and pain centers.
Cryosurgical Concepts (Boynton Beach, Florida) sells the CryoProbe which supplies nitrous oxide under high pressure to achieve extreme cold (below 17o Fahrenheit) for the destruction of unwanted tissue such as verrucae (skin lesions).
Tests for peripheral neuropathy
Anodyne Therapy (Tampa, Florida) featured its patented light therapy, described as monochromatic infrared photo energy (MIRE) to treat peripheral neuropathy in the foot and heel which is caused by poor circulation. Increasing microcirculation was clinically shown using scanning laser Doppler images to help reduce inflammation and neuropathic pain and to improve sensation. This treatment can be used adjunctively with a physical therapy program to reduce pain. It also can be used to treat knee, elbow and sacral pain.
NeuroVasix (Tulsa, Oklahoma) featured its MicroVas Vascular Therapy (MVT) for the treatment of diabetic and non-diabetic peripheral neuropathy. The MVT system generates ionic impulses that pass through the limb or body using strategically placed carbon emitter pads. These impulses cause neuromuscular stimulation of the venous muscle pump.
A small trial has shown that MVT resulted in a reduction or elimination of drug use by patients. However, little is known about the mechanism of action of MVT and there is a need for more studies with precise measuring methods, such as quantitative nerve conduction velocities and amplitudes of evoked responses, for objectively assessing nerve function. MVT also has been used successfully to heal diabetic foot ulcers. This is achieved by upregulation of the venous muscle pump, which increases the concentration of oxygen in the wound area and leads to improved blood flow.
Implants, fixation devices and bone fillers
Nexa Othopedics (San Diego) recently introduced the NexFix stainless steel compression pin used for the internal fixation of small bone fractures. It combines the compressive strength of a screw with the ease of inserting a pin. Its StayFuse fusion device is an interlocking two-piece titanium screw that snaps together for intramedullary fusion of small bones.
In 2005, Nexa acquired Bioprofile (Grenoble, France), a manufacturer of pyrolytic carbon implants. Its Futura foot and ankle product line includes the Primus and Classic flexible big toe implants, Hemi toe and metatarsal phalangeal joint implants and a conical subtalar implant for correcting flatfoot deformities. Its OsteoCure synthetic bone graft is highly porous and is composed of polyglycolic acid fibers, calcium sulfate and surfactant.
Arthrotek, a subsidiary of Biomet (Warsaw, Indiana), displayed its Weil-Carver resorbable hammertoe implant for proximal interphalangeal joint arthrodesis. It is implanted using the surgical technique developed by Lowell Scott Weil Sr., at the Dr. William M. Scholl College of Podiatric Medicine, and Andrew Carver of San Francisco. Arthrotek markets a line of resorbable fixation devices made from copolymers of lactic and glycolic acids, which includes screws, sheets, mesh, plates, rivets and pins.
Stryker Orthopaedics (Mahwah, New Jersey) offers a broad line of implants for the management of foot and ankle fractures and deformities that include an external fixation system, cannulated screws, compression screws, calcaneal plate, and anterolateral tibia locking plates. The company also markets a biodegradable ankle fixation system fabricated from polylactide/trimethylenecarbonate that is produced by Inion (Tampere, Finland).
Wright Medical Technology (Arlington, Tennessee) introduced three new internal fixation devices for foot and ankle surgery, a screw for Jones fractures (fifth metatarsal), a multi-use compression screw for subtalar fusions and a claw locking compression plate.
Smith & Nephew (Memphis, Tennessee) featured its Exogen bone-healing system, the only bone stimulation device approved for accelerating the healing of certain fresh fractures. It entails a 20-minute daily treatment with low-intensity ultrasound and has been clinically proven to heal fractures 38% faster than primary fracture management alone. It also heals 86% of non-union fractures treated with surgical fixation.
Integra LifeScience (Plainsboro, New Jersey) recently entered the podiatry device market with its acquisition this year of Kinetikos Medical (Carlsbad, California), a supplier of foot and ankle and upper extremity implants, and Miltex (York, Pennsylvania), with its line of podiatric surgical instruments. Integra has just launched TendonWrap, a tendon protector sheet.
Zimmer (Warsaw, Indiana) recently launched the CopiOs flexible and porous bone void filler that is made of calcium phosphate dibasic in a collagen scaffold. When mixed with bone marrow aspirate, it becomes osteogenic, osteoinductive and osteoconductive.
IsoTis OrthoBiologics (Irvine, California) markets Accell DBM 100, an osteoinductive demineralized bone matrix that contains natural human bone morphogenic proteins (nhBMPs) for stimulating new bone growth. Accell Connexus is composed of demineralized protein particles that are mixed with an osteoinductive carrier that is made by the proprietary AccelRx process. The carrier boosts osteoinductivity by unlocking nhBMPs and other growth factors. Accell Total Bone Matrix is a preformed bone graft solution made completely of demineralized bone. It readily absorbs cells present in bone marrow aspirate which creates a composite graft with the three essential bone forming elements – osteogenic, osteoinductive and osteoconductive – for promoting bone growth. IsoTis is accredited by the American Association of Tissue Banks (McLean, Virginia).
Arthrosurface (Franklin, Massachusetts) exhibited its HemiCAP great toe resurfacing system that restores surface geometry of the metatarsal head and preserves functional structures using a 3-D mapping system and a contoured articular resurfacing implant. The HemiCAP implant is contoured to the area of damaged cartilage and is designed to protect the remaining, normal cartilage in order to prevent further damage to the joint while maintaining the patient’s range of motion. The HemiCAP is indicated for use in treatment of patients with the following clinical conditions: hallux rigidus, hallux limitus, hallux valgus and an unstable or painful metatarsal phalangeal joint.
MetaSurg (Houston) displayed its titanium internal fixation systems for use in mid- and forefoot surgery. Its Ti6 modular system is essentially six different systems in one and can be assembled with the choice of modules needed by the surgeon.
ERMI’s (Decatur, Georgia) Flexionater is a home motion therapy device which is used daily for one hour of end-range stretching with applied loads that are comparable to those used by a therapist in the rehabilitation clinic. This protocol enables patients to maintain, and even gain, motion between physical therapy visits. Indications for use are post-bunionectomy and for a stiff great toe.
The ERMI knee/ankle Flexionator can generate loads up to several hundred foot-pounds of torque, sufficient to stretch stiff joints. The Extensionater is designed to provide physiologic joint mechanics and increase motion for the metatarsal phalangeal joint. ERMI is a new entrant in podiatry. Its products have been used for treating stiff shoulders, elbows and knees.