One of the most amazing things about the human body is its ability to repair itself. Lacerations, punctures, abrasions all heal with little or no care. Chronic wounds, those that persist day after day, are a small subset of wounds but they compose a troublesome minority. They include, but are not limited to, diabetic foot ulcers (DFU), venous leg ulcers (VLU), and pressure ulcers (colloquially known as bedsores). These represent the body’s failure to fix itself.
Approximately 6.5 million Americans are affected by chronic wounds. Because of certain medical trends (aging populations, increased occurrence of diabetes, the rise in obesity), chronic wounds are becoming more common, occurrences increasing at around 8% per year. The US spends $25 billion annually treating these wounds, which are the most expensive complication following surgery. Wounds are a major source of bacteria that drive infection rates at hospitals.
Initial treatment of a chronic wound involves regular cleaning and covering the damaged area with wound dressings and bandages. In many instances, the physician will debride the dead or inflamed tissue, removing it by various methods ranging from plucking it away with tweezers to introducing maggots to the wound where they consume the damaged tissues.
However, some wounds still fail to heal. These ulcers require advanced therapies. These include:
- Electrical stimulation
- Negative pressure
- Hyperbaric oxygen
- Growth factors
- Skin substitutes
- Stem cells
Nursing home healthcare professionals will select the specific treatment best suited for their patients. A new treatment option using electrical stimulation, the Bioelectrical Signal Therapy (BST) Device from E-QURE may soon present a very cost and time-effective solution.
Clinical studies show that using the BST leads to a wound closure rate 5 times higher than a control group, with 45% of treated patients experiencing full wound closure. Full wound closure results in a significant reduction in treatment costs. Reimbursement via Medicare is already established, and compares very favorably with the costs of current standard of care. Electrical stimulation has been shown to be beneficial in a number of studies, according to an article in Advanced Wound Care.
Human cells are, among other things, electrical units. As described in an article in Diabetic Foot & Ankle, “Injury to the epithelial layer disrupts the body’s naturally occurring electrical current therefore creating an electrical field. This electrical field, along with chemotaxis and injury stimulation, guides epithelial cell migration during wound healing.” The article further concludes, “Electrical stimulation is believed to restart or accelerate wound healing by imitating the natural electrical current that occurs in injured skin.”
The challenge in the U.S. has been that there is no FDA approved electrical stimulation device available. In the next few months, the BST device will commence a pivotal multi-center, double-blind, placebo controlled, randomized registration trial. The study will evaluate 90 patients who have Stage III and IV ulcers. These are the hardest ulcers to treat. Top line results are expected in 2018 and if the results show efficacy, the BST may be available for use in nursing homes in 2019.
Healthcare providers in nursing homes can administer the BST with the aim towards reducing chronic wounds including bedsores for patients who are not mobile. For patients who do have mobility, healing the chronic wound can lead to faster overall recovery and a better quality of life while in nursing home care. Treatment with the BST is given for 30 minutes, 3 times per day, over the course of 45 to 60 days. This compares very favorably to standard of care methods which require in-hospital treatment for up to 23 hours per day. While the BST is evaluated by the FDA, healthcare providers have the following options.
Negative Pressure Wound Therapy (NPWT)
NPWT has antecedents dating back to the Roman legions. “Individuals who were thought to have hereditary powers of healing were assigned to give direct suction by mouth to the wound. This treatment proved so successful that they were considered indispensable to the Roman army, and even Cato had a group of these sucking healers in his African campaign,” as reported in the Journal of the American College of Clinical Wound Specialists.
The modern day version of this method involves using a vacuum device to draw out excess fluid and increase the flow of blood to the wounded area. The procedure has been shown to improve healing and the treatment can be done at home. However, a recent study found that risks of NPWT include risk of infection, impacting 21% of patients in the study.
Hyperbaric Oxygen Therapy (HBOT)
HBOT works by exposing the body to 100% oxygen at pressure levels higher than would exist in a normal setting. Although some evidence of its efficacy is well-established, the procedure is not without risk and can only be administered in clinics and hospitals where these large chambers exist. Only 1% of nursing homes have hyperbaric oxygen chambers.
Growth factors such as vitamins and hormones are useful in chronic wound healing because they use the body’s own cells to do the healing. They are most often applied topically, which helps limit side effects and are used most often to treat chronic diabetic foot ulcers and venous leg ulcers.
Skin substitutes come in many forms, but they all do just what the name implies – they help heal the wound by taking the place of damaged skin tissues. They range from human allografts (temporarily covering the wound with skin taken from human cadavers) to synthetic materials and permanent substitutes like epicel, also called cultured epithelial autograft (CEA), it only provides the epithelial (outermost) layer of skin.
Stem cells have incredible potential for medical science in general, and that includes chronic wound care. They release soluble growth factors and cytokines that can modulate inflation and stimulate new vessel formation.
Chronic wounds are a growing problem in the population because of several different factors ranging from a graying population to widespread obesity. Medical science is making progress in the treatment of these wounds on several fronts. The diversity of our toolkit is important in the treatment of these wounds because they have diverse causes. In some instances, growth factors coupled with hyperbaric treatment may be the optimal treatment. In others, a simple electrical stimulation, even done in the home, might correct the problem. Costs vary significantly based on the specific treatment modality used. Treatments that fully heal the wound and that can be administered easily in any setting, from hospital, to nursing home, to private home, may be most advantageous both in terms of efficacy and price. As ever, further research is needed.
Ron Weissberg is the chairman of E-QURE.