The research of the ‘70s and ‘80s seems to have paid off in the array of high-tech bioactive wound care products and innovative dressings that have emerged on the market in recent years. We have seen new and improved hydrogels, alginates, growth factors, living skin equivalents and vacuum assisted closure, not to mention new classes of antibiotics to cover emergent drug resistant organisms and modifications of existing antibiotic classes to increase the spectrum of activity. Did I mention silver ion dressings and combination dressings?
We have been given an armamentarium unlike we have ever seen in the treatment of diabetic foot ulcers and infections. As far as invasive treatments go, more aggressive distal bypass techniques have been developed to correct perfusion deficits. We have also seen more aggressive reconstructive techniques designed to create a “functional limb.” Adjunctive therapies such as hyperbaric oxygen therapy and electrical stimulation are gaining increasing acceptance in the treatment of diabetic foot wounds. All of these advances are in the name of limb salvage and yet amputation rates have gone up and not down. Why is that?
The Healthy People 2000 Initiative published by the Department of Health and Human Services attempted to reduce amputation rates by 40 percent by the year 2000. However, amputation rates for non-traumatic lower extremity amputations actually went up from 50,000 to 86,000 amputations per year. The St. Vincent’s Declaration in Europe did not fare any better.
The reasons for this are far more complex than this column can explain. Certainly, obesity has become a national epidemic and there has been a corresponding increase of type 2 diabetes and diabetes-related complications. We have also identified more diabetic patients via aggressive screening campaigns.
The establishment of DRGs and prospective pay systems has led to a shift from acute care settings to long-term care and home settings. This has stimulated the medical/pharmaceutical industry to research, develop and ultimately market products and devices designed to increase healing rates, decrease healing times and costs, increase the quality of life and, ultimately, decrease amputation rates. Yet the direct cost of care to treat diabetic foot ulcers has steadily gone up to $10.91 billion a year. So … have we failed to hit the mark?
A Closer Look At The Efficacy And Costs Of Emerging Modalities
Perhaps one reason for these increases in amputation rates is our failure to stick to an algorithm. Granted, these new technologies have become valuable additions to our armamentarium and have proven their effectiveness in the healing of diabetic foot ulcers and infections. They have been developed as a direct result of our increased understanding of the wound healing cascade at the cellular level.
For example, the selective use of growth factor therapy has been shown to be efficacious. In a multi-center double blind clinical trial, PDGF-BB (Regranex) increased the incidence of complete healing by 50 percent versus 35 percent for placebo. The cost of a tube of Regranex hovers around $500 per tube. Although it is hard to quantify, it is estimated that it takes approximately 1.5 tubes of Regranex to heal a diabetic foot ulcer.
In another clinical trial, human fibroblast derived dermal substitute (Dermagraft) demonstrated complete closure of diabetic foot ulcers 30 percent of the time versus 18 percent of the time for the standard of care group after 12 weeks of therapy. The cost of using human fibroblast derived dermal substitute (Dermagraft) ranges from $1,000 to $1,200 per application.
Although it is not a new technology, hyperbaric oxygen therapy has shown efficacy in the treatment of diabetic foot ulcers. Although the study designs have not been well controlled, there has been enough compelling data for Medicare to reverse its stand on reimbursement for HBO. The average cost of hyperbaric oxygen therapy ranges from $250 to $500 per session with an average of 20 sessions, not including hospital charges.
Asking Tough Questions About Complacency And Use Of New Products
However, none of this changes the fact that the cost of treating diabetic foot ulcers has grown to $10.91 billion per year. To repeat, the amputation rates have gone up and not down.
I submit that a significant portion of the problem is our failure to adhere to an algorithm that has been so well established by numerous authors.
What good are these new technologies if we have not yet first established whether the limb is perfused well enough to heal and, if not, make an aggressive attempt to help achieve revascularization? What good are these new technologies if we have not adequately debrided nonviable tissue, including bone and tendon if necessary, to establish a clean wound bed? What good are these new technologies if we have not identified infection and dealt with it locally and systemically? What good are these new technologies if we do not adequately offload these wounds? What good are these new technologies if we do not recognize the fluid nature of these wounds and match the dressing to the wound as the wound changes?
Our new technologies have lengthened the time between wound inspections and may have created a sense of complacency. These technologies are increasing our time to make decisions about changes in wound care and often the changes may be too late to make a difference.
We must also consider that, although it is politically unpopular to say, due to the widespread availability of these products and technologies, wound care patients may have been placed in the wrong hands. Wound care centers are becoming the new “doc-in-the-box” at every level, including hospitals, clinics and private offices. The fears that were voiced several years ago, while I served as a member of the educational team for Ortho-McNeil Pharmaceuticals during the development phase of Regranex, seem to have come true. The fear is namely that physicians may be utilizing these technologies at inappropriate times in inappropriate wounds without a clear-cut wound algorithm.
These statistics indicate to me that we are far from practicing optimal cost-efficient care in the treatment of diabetic foot ulcers. If these trends do not begin to reverse themselves, then the economic overseers in our payer system may conclude that the cost of these new technologies has not produced a net decrease in the cost of care or amputation rates. Therefore, we may see reimbursements be reduced or eliminated altogether.
When these technological advances are used in the proper setting, they can help reduce costs and increase healing rates in less time. However, before we order our next dressing or device, we need to do “first things first” and use the algorithm to support our dressing decisions. These statistics indicate to me that wound care has truly emerged as a specialty and should be practiced as such.
Dr. Brill practices at the Limb Salvage Center at the BrillStone Building and is President of the BrillStone Corporation in Dallas. He is a Fellow of the American College of Foot and Ankle Surgeons and is also a consultant in wound care and reconstructive foot and ankle surgery at the Wound Care Clinic at Presbyterian Hospital in Dallas.
Dr. Steinberg (pictured) is an Assistant Professor in the Department of Orthopaedics/Podiatry Service at the University of Texas Health Science Center.
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