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A new electronic device successfully healed the most stubborn chronic wounds in six weeks or less. It also regenerated necrotic tissue, making surgical intervention unnecessary, according to the results of a study presented at The American Academy of Anti-Aging Medicine’s 8th International Congress in Las Vegas. With an aging population increasingly at risk for chronic wounds and the cost of chronic wound care expected to exceed $2.4 billion by 2006, according to industry reports, the ElectroRegenesis Therapy Device (ERTD) manufactured by ElectroRegenesis in Pacific Palisades, CA, holds great promise to heal wounds more quickly and thoroughly than currently available standard treatments.
The study, led by Bok Y. Lee, MD, professor of surgery at New York Medical College in Valhalla, included 25 chronic wounds with an average duration of three years not responding to standard conservative treatment. Wounds included long-term decubitus ulcers, amputations, diabetic lesions, and paraplegic and quadriplegic wounds.
All 25 patients in the study were hospital inpatients. The wounds were treated with a direct current of a maximum of 4 milli-amperes of one polarity for 11 minutes and then the current of the opposite polarity for another 11 minutes. A single treatment lasted 31/2 hours. Patients received five treatments per week until their wounds healed completely.
The average time to complete wound healing was 14 treatments, or about three weeks of treatment five times a week. "The longest time a patient took to heal was six weeks," notes Alfred J. Koonin, MD, director of medical research for ElectroRegenesis in Pacific Palisades.
"The ERTD represents a major advancement for treating the most chronic, treatment-resistant wounds," says Lee. "The device is a safe, non-invasive therapy for a range of serious, difficult-to-treat health problems."
Researchers also found ERTD eliminates the need for surgical debridement of necrotic tissue, says Koonin. "Many of the patients were very elderly and infirm, and would not have been candidates for surgery," he notes. "As the population ages, the need for less invasive treatment for chronic wounds becomes critical."
To qualify for the study, patients had to have had a chronic wound that failed to respond to standard treatment for at least three months. Patients continued their current wound management treatment while receiving ERTD stimulation.
The ERTD measures roughly 12 inches by 12 inches and stands about three or four inches high. ElectroRegenesis is also developing a smaller unit for home use. Neither unit has received approval from the Rockville, MD-based U.S. Food and Drug Administration.
"The unit is simple to use and our hope is that eventually patients will be able to begin initial treatment in an outpatient clinic and then use the take-home unit with the help of a family [member] or professional caregiver at home," says Koonin, adding that a much larger 10-center study of ERTD in 200 patients with chronic wounds is currently under way.
Before ERTD treatment, foam bandages soaked in ordinary tap water are wrapped above and below the wound. A black silicon bandage is wrapped over the foam bandage and wires leading from the ERTD are clipped to the silicon bandage.
None of the patients in the study experienced side effects from the treatment other than mild rashes from the wraps that resolved quickly once the wraps were removed. "Most patients don’t feel anything except a mild tingling during treatment," says Koonin. "The current running on this machine is much lower than any other electric stimulation device in use medically for any condition."
Koonin notes that physicians who had been treating these patients "were more than surprised" at how quickly and completely the wounds healed. "Several patients had significant improvement in two treatments. None of the patients required surgery. Necrotic tissue appears to regenerate."
One unexpected side effect Koonin hopes will be better understood as results from the multi-center study are analyzed is the cognitive improvement seen in several patients with dementia included in the initial 25-patient study. "About half the patients in the study had some dementia. As a side effect of treatment, we noticed significant improvement in their cognitive behavior as treatment progressed."
[Editor’s note: For further reading on the use of electrical stimulation for wound healing, see also: Sheffet A, Cytryn AS, Louria DB. Applying electric and electromagnetic energy as adjuvant treatment for pressure ulcers: A critical review. Ostomy/Wound Management 2000; 46(2):28-33, 36-40, 42-44. Gardner SE, Franz RA, Schmidt FL. Effects of electrical stimulation on chronic wound healing: A meta-analysis. Wound Repair and Regeneration 1999; 7(6):495-503. Kloth LC, McCulloch JM. Promotion of wound healing with electrical stimulation. Advanced Wound Care 1996; 9(5):42-45.]