Posts Tagged hydrogel

Prevalence, Impact, & Treatment options for Diabetic Foot Ulcers & Wound Healing


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.

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Passive Restraint Solution to Prevent Congestive Heart Failure (CHF) following Myocardial Infarction


Drs. Ryan Krone & Karen Havenstrite discussed COR Innovations’ solution to preventing congestive heart failure (CHF), following myocardial infarction (i.e. heart attack) with a minimally-invasive, device-based technology, at http://www.bio2devicegroup.org .

Heart failure affects 5.8 million people in the U.S. alone and is responsible for nearly 1 million hospitalizations each year. The cost to healthcare industry in 2010 was a staggering $25B and is projected to triple to $75B by 2030. There is only 50% survival rate, 5 years after the diagnosis. Heart failure is a progressive disease. Myocardial infarction, commonly known as a heart attack, results from the interruption of blood supply to a part of the heart, causing heart cells to die. This is most commonly due to occlusion or blockage of a coronary artery following the rupture of plaque clogging the walls of an artery. A vicious circle of ischemia, decreased cardiac output and reinfarction makes it largely incurable and progressive disease. First line of treatment regimen begins with prescription medications to help heart function and may include Beta Blockers, Diuretics, and ACE Inhibitors. But when the heart is greatly damaged and needs additional support, there are device based interventions including pacemakers and implantable Defibrillators. And finally there are surgical options that include heart valve repair, coronary artery bypass, implantable heart pump and finally heart transplant. Paracor was a company that offered passive restraint device to offload the weakened heart muscle. Though the device was less invasive compared to sternotomy, it was an invasive surgery, with added complications of severe immune response requiring the need for immunosuppressive medications with severe side effects and was therefore offered only to end stage patients.

COR Innovations has a novel passive restraint solution that encapsulates the heart in hydrogel which is highly biocompatible, eliminating the severe immune response. Further, it is significantly less invasive since the liquid hydrogel can be administered through the catheter and it can polymerize in-situ. This is FDA approved material, adheres to the heart, and is adjustable. However, there are challenges that the team is currently working to resolve. While the material offers great advantages, is perfectly suitable for the application, is biocompatible, and it disintegrates and leeches out in about a year, the bigger challenges are with respect to delivery. Once mixed, the material polymerizes in 30 seconds and the challenge is to ensure that the time is sufficient to encapsulate the heart. Also the ideal level of thickness versus the strength of the polymer for optimal restraint has to be found. The unique method of delivery makes it possible to deliver non-invasively but poses these challenges. Discussing the regulatory pathway, Havenstrite shared that they would follow the PMA pathway, given that this is a new material with a new indication. The topic generated great interest and was followed by Q&A.

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