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Home / Specialties / Dermatology / Nitric Oxide Series, Part Eleven: Wound Care with Nitric Oxide Therapy — The Basis for The Anodyne System

Nitric Oxide Series, Part Eleven: Wound Care with Nitric Oxide Therapy — The Basis for The Anodyne System

Use of the Anodyne Therapy System (ATS) appears to elevate NO locally so that blood flow can be increased directly at the site of application. This increase in blood flow is the basis of the therapeutic benefits of the ATS on pain and neuropathy, as we discussed earlier. Recall that arterial AND venous dilation occur in the presence of NO; throughput at the wound site is increased. Wounds such as diabetic ulcers, venous stasis ulcers, and pressure ulcers fail to heal without adequate blood flow to and from the site of injury. The ATS, which certainly increases circulation, might be expected to assist in the healing of wounds for reasons mentioned in Part 10, last week.

Part Eleven: Wound Care with Nitric Oxide Therapy — The Basis for The Anodyne System

Use of the Anodyne Therapy System (ATS) appears to elevate NO locally so that blood flow can be increased directly at the site of application. This increase in blood flow is the basis of the therapeutic benefits of the ATS on pain and neuropathy, as we discussed earlier. Recall that arterial AND venous dilation occur in the presence of NO; throughput at the wound site is increased. Wounds such as diabetic ulcers, venous stasis ulcers, and pressure ulcers fail to heal without adequate blood flow to and from the site of injury. The ATS, which certainly increases circulation, might be expected to assist in the healing of wounds for reasons mentioned in Part 10, last week.
The first study to document an ATS-mediated improvement in wound healing was published in the peer reviewed journal, Advances In Skin and Wound Care 12:35, 1999. The study described some of the results from an IRB approved, double blind study on VA patients with venous stasis ulcers of long duration (6-40 years!). To enter the study the patients exhibited a current wound(s), which had to be present for at least a year, AND demonstrating non-healing with other treatments. Under the protocol, patients treated themselves at home for 30 min. per day with the ATS using only a wet to moist covering held in place with a stocking. Half of the patients were treated with placebo ATS devices offering warmth alone and the other half received active treatment. Within 3 weeks all the patients on active ATS showed remarkable acceleration of healing while those on placebo ATS did not. The physicians, for ethical reasons, began treating all patients in the study with active ATS. Additionally, patients with non-healing diabetic foot ulcers were treated with the ATS at another hospital. These studies were not placebo controlled, but the patients had failed to improve when treated with most, if not all, conventional wound care products. These patients were treated for 1-3 times per week as outpatients! These wounds also healed quickly.
The authors waited for over a year to publish these results to determine the quality and duration of healing. Subsequent evaluation (including capillary refill time, tissue integrity, and minimal scarring) demonstrated excellent tissue remodeling and, as a result, no subsequent breakdown in the healed wounds was observed. As might be expected, punch biopsies, for collagen analysis were not performed because patients and physicians were reluctant to “reinjure” the wound that had finally healed after so many years. Further follow up at four years on a number of patients has shown no reoccurrence of the wounds. Interestingly, we used a Scanning Laser Doppler (Moor Instruments) to measure the micro perfusion in the healed wound sites and observed that, four years after treatment, the blood flow in the healed area was 3 times better than blood flow in the surrounding area where no wound had ever occurred. These findings of excellent, very local tissue remodeling and presumed angiogenesis at the healed wound site would be expected with NO mediated increases in local blood flow and NO mediated enhancement of vascular and epithelial growth.
The results of this study have encouraged numerous wound centers to evaluate ATS for the treatment of refractory wounds. Dr. Mark Melin of Minneapolis recently reported success in more than 75% of patients during an interview aired on the Ivanhoe Network. Evaluators in Wisconsin have reported improved wound healing in refractory venous ulcers and improved viability of skin flaps using ATS. This center has also noted increases in TcPO2 values after use of ATS. Increases in TcPO2 cannot be attributed to anything else but an increase in oxygen availability at the site, which is believed to result from the vasodilation induced by NO. Lastly, a well-known rehabilitation hospital in Colorado has reported high levels of success in treating previously unresponsive pressure ulcers. Other researchers are evaluating the speed of healing of diabetic ulcers using ATS.
Clinical reports indicate that ATS is being successfully used adjunctively along with numerous dressings including Fibracol and Panifil. Since ATS treatments are of short duration (30 minutes per day), non-invasive, and can be self administered by the patient adjunctively along with most wound dressings, the ATS appears to be a promising new innovation in wound care. Addtionally, by reversing diabetic peripheral neuropathy and restoring protective sensation, ATS may be able to reduce the incidence of diabetic foot ulcers and amputations in the first instance.
In summary, the Anodyne Therapy System is the first non-invasive medical device that has been shown to locally affect NO levels. In view of the essential physiological role NO plays in wound healing and pain reduction, the ATS (by affecting NO) may be of substantial clinical benefit to many patients.    The ATS may provide its most meaningful clinical benefits to people with diabetes. These individuals exhibit impaired NO metabolism, reduced blood flow to nerves and tissue and consequent peripheral neuropathy, non-healing wounds, amputations and reduced life expectancy. Initial clinical research and reports show that ATS supports wound healing, reduces pain and reverses peripheral neuropathy in people with diabetes. Thus, it appears very likely that the ATS can improve the quality of life for people with diabetes and reduce direct and indirect cost associated with this chronic disease.
The next article will be the last in this series. It will summarize the role and importance of NO for patients, their physicians, and the healthcare profession in general.
Dr. Tom Burke received his PhD in Physiology from University of Houston and Post Doctoral Training at Duke Medical School, He was an Associate Professor of Medicine and Physiology at the University of Colorado Medical School. He has authored more than 70 published scientific clinical articles and has been a visiting scientist at the Mayo Clinic, Yale University, University of Alabama, and University of Florida. He is a recognized international lecturer on cell injury and nephrology.