Dr. Alex Reyzelman, a podiatric surgeon in private practice since 1988, shared about the prevalence, impact on patients, and treatment options for diabetic foot ulcers, at www.bio2devicegroup.org event.
Overweight and obesity, defined as abnormal or excessive fat accumulation is on the rise, worldwide. Along with obesity, diabetes, once considered a disease of affluence, is also on the rise. In 2002, 18.2 million people, or 6.3 percent of the population, had diabetes. Diabetes currently affects over 285 million people worldwide, and the number is expected to reach 438 million, by the year 2030. Current direct and indirect costs to the society, of diabetes, in the US alone, total over $174 billion, annually. One of the most common complications of diabetes is, foot ulcers. Between 60 and 70% of those with diabetes, develop peripheral neuropathy, or lose of sensation in their feet, and about 25% develop a foot ulcer. Feeling of pain is a gift for humans and these patients lose that feeling.
About 15% of the diabetic foot ulcers result in lower extremity amputation. About 85% of nontraumatic lower limb amputations are performed due to diabetic ulcers. After a major amputation, about 50% of patients have their other limb amputated within 2 years, and about 45% of patients with diabetic foot ulcer amputation, die within 5 years. The relative 5-year mortality rate after limb amputation at 45%, when compared with cancer, is second only to lung cancer (86%). (5-year mortality rates are: for Colorectal cancer 39%, Breast cancer 23%, Hodgkin’s disease 18%, Prostate cancer 8%). After sharing some of these most staggering and shocking statistics, Dr. Reyzelman discussed the standard of care and treatment options, for diabetic foot ulcers.
The treatment of a diabetic neuropathic foot ulcer, usually consists of debridement of necrotic or nonviable tissue, treatment of infection, use of a saline moist wound dressing, possibly use of a device or some manner of off loading that protects the wound from pressure or trauma, and arterial revascularization. If a wound remains unhealed after 4 weeks, then it is a cause of great concern, said Dr. Reyzelman. If the process is strictly followed, then 24% of the wounds heal, at the end of a 12 week period, and at the 20 week period, 30% of them heal. However, despite following the process, a great number of wounds do not heal. Reasons for slow healing include, prolonged inflammatory phase, tissue destruction, wound edema, bioburden, biofilm formation, and hypoxia.
Dr. Reyzelman went on to discuss the type of wound healing products, currently in the market, that include, films, hydrogels, hydrocolloids, hydrofibers and so on. Wet to dry films are widely used and help pull out the nonviable tissue. However, often they also end up disturbing the wound as well. Hydrogels are not absorptive and they often keep the wound wet. Maintaining a balanced, moist environment is important for effective healing. In using hydrofibers, the mechanics of exudates handling are complex. Too vigorous absorption can desiccate the wound and dry it out. Bioengineered skin (Apligraf) and human dermis (Dermagraft) are new types of biologically active implants for ulcers that are derived from fibroblasts of neonatal foreskins. The negative pressure wound treatment or NPWT technology platform, includes a collection of products that deliver negative pressure or a vacuum, to promote wound healing. This is most useful for deep wounds. There is hyperbaric oxygen therapy and there is compression therapy for edema to get rid of the swelling, and there are silver based therapies. None of these products have PMA. Only 3 products have PMA, and that was before 2001.
Dr. Reyzelman also discussed natural botanical-based wound care options that include Aloe Vera, honey, and WINVIVO wound ointment. Aloe Vera has anti inflammatory and analgesic properties. Honey exhibits anti-microbial, antioxidant, and anti inflammatory properties. WINVIVO is based on botanical medicine from Asia, and exhibits anti-inflammatory, anti oxidant, anti microbial, and analgesic properties. Hearing about this product, sparked a sufficient interest and Dr. Reyzelman shared further about its use with 15 of his own patients. These patients had chronic foot ulcers and they were given instructions to only apply WINVIVO product. They were not using any other therapy and came for office visit, once a week, got their wound cleaned and debrided. Recently, the results of Dr. Alex Reyzelman’s ground breaking clinical studies on WINVIVO, has been published in the peer-reviewed journal of “Advances in Skin & Wound Care.” The results were striking and impressive. WINVIVO was well tolerated and demonstrated the ability to simultaneously support granulation tissue formation; decrease the amount of exudate, edema, and malodor; and reduce pain. WINVIVO treatment lasted for 3 to 12 weeks and resulted in a mean 88% wound closure, with 4 wounds healing completely. Dr. Reyzelman is assuming that highly beneficial result from the use of this product, may be due to its multi-modular properties.
The presentation was followed by Q&A.