Has The Algorithm Been Lost In New Technology Buzz?
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.