July 21, 2008 -- The American Podiatric Medical Association (APMA) says that Hyperspectral Transcutaneous Oxygen Montitoring (HTcOM), effectively measures real-time oxygen levels surrounding foot ulcerations commonly seen in diabetics, and can be used to determine a successful treatment plan.
"Hyperspectral imaging will quickly become one of the most important tools physicians can use to assist diabetic patients in wound care treatment," said Aksone Nouvong, DPM, an assistant clinical professor at UCLA's David Geffen School of Medicine and a podiatric physician involved in a study of the technology. "One of the most important findings we have discovered while studying HTcOM is that if a patient already has an existing foot wound, this technology can tell right away whether or not the ulcer has the ability to heal on its own." Non-healing ulcers are a leading cause of lower limb amputations.
Findings of the National Institutes of Health-funded study will be presented as two posters at the APMA's 96th Annual Scientific Meeting in Honolulu, which runs July 24-27. Publication of the study's final results is expected in the fall of 2008.
Study data on HTcOM was collected in a Phase 2 longitudinal study at the National Institutes of Health (NIH), and looked at 66 type 1 and 2 diabetic subjects with at least one foot ulcer. Over six months, HTcOM was used to monitor oxygen levels at the site of the various ulcerations and accurately predicted which ulcer would heal. Interim data of 28 subjects that had completed the study after six months showed that 29 of the 36 ulcers had displayed positive healing potential after being treated based on HTcOM measurements. The positive predictive value for healing was 100 percent with this interim data cut.
According to the APMA, "every 30 seconds, a lower-limb amputation is performed somewhere across the globe due to complications related to diabetes. According to HyperMed (Burlington, MA), its OxyVu product , which uses proprietary technology in the first medical application of hyperspectral imaging, is the only FDA-approved medical hyperspectral system to non-invasively and quantitatively assess tissue oxygenation in patients with diabetes and peripheral arterial disease. "The measurements taken with HTCOM are calculated in approximately 15 seconds, and can then be used to determine the most successful treatment plan for that particular wound."
Dr. Lee Rogers, DPM, Director of the Amputation Prevention Center at Broadlawns Medical Center and a clinical user of the OxyVu system, commented "the use of OxyVu hyperspectral imaging truly benefits clinical practice, providing real-time data on tissue oxygenation that allows clinicians to diagnose peripheral arterial disease, predict wound healing and determine level of amputation."
The APMA says the technology may make its way into physicians' offices across the country after the completed research on HTCOM is released in September. "Many lower-limb amputations currently being performed have to be done at an unnecessarily high level -- often because the physician has no way of knowing the exact spot at which to perform an effective amputation," Dr. Nouvong said. "A patient who might have had an entire foot amputated may be found to only need to have their big toe done after being assessed with HTCOM."
Hyperspectral Technology (HT) is a novel medical imaging modality that combines advanced optics with sophisticated mathematical algorithms to identify subtle changes in composition from reflected light. The technology was developed initially by the Department of Defense for use in aerial espionage and satellite surveillance.
HyperMed's OxyVu measures oxyhemoglobin and deoxyhemoglobin to enable clinicians to assess tissue metabolism. The company's initial focus is on complications of diabetes and peripheral arterial disease. Through a simple thirty-second non-invasive scan, a physician gains valuable insights that aid in planning of advanced treatment interventions and surgery, which may lead to earlier interventions, reduced level of amputations and faster case resolutions.