Medical Device Daily Washington Editor

Diabetic ulcers can wreak havoc on the life of the patient, and also on the patient’s friends and family. According to a 1999 article in the journal Diabetes Care, the typical patient between the ages of 40 and 65 who suffered from a foot ulcer in the mid-1990s incurred almost $28,000 in medical costs alone, making this a profoundly expensive condition. Add in time missed from work and the cost of treating these lesions is staggering.

Thankfully, an end run around this state of affairs does not have to involve uber-costly scanning or other assessment measures.

An article in the January 2007 edition of Diabetes Care reports the results of a trial of an infrared thermal probe designed to predict the occurrence of foot ulcers, and the results suggest that this low-tech device may yield large returns on investment.

Xilas Medical (San Antonio, Texas), maker of the TempTouch home infrared thermal probe, closed the trial roughly a year ago, and the device has been commercially available since last March, when it won FDA 510(k) clearance. Commercial results are only now arriving.

Designed to detect impending foot ulcers by picking up the increased temperatures characteristic of the inflammation that precedes the onset of ulcers, the TempTouch is selling briskly to institutions, Xilas said, and it expects to see sales to individual patients climb and in the future match institutional sales.

The trial showed that consistent use of the device cut the incidence of foot ulcers to 8.5%, a huge drop from the roughly 30% observed in the two control groups in the study. Among the inclusion criteria was a previous history of diabetic foot ulceration, and the 173 enrollees undertook standard therapy, structured foot examination, or enhanced therapy with the study article.

The sponsor provided each subject with therapeutic footwear, diabetic foot education, and regular foot care, and those in the study arm recorded the temperature measurements from six identical sites on each foot.

The reason for checking the same spot on each foot is that temperatures do not remain constant, and the temperature difference is the only reliable way to detect a hyper-thermal state. The protocol deemed any differences in temperature that exceeded 4 F (2.2 C) as indicative of an impending ulcer.

Larry Lavery, MD, professor of surgery at the Texas A&M University Health Science Center (College Station), said that he found the results “very compelling.” Lavery, the lead author of the article, wrote that rates of ulcer recurrence “can be as high as 58% to 83% within 12 months” of the first such event.

“It is not unusual for these problems to require radical surgical procedures if gangrene and infection persists, as evidenced by the 90,000–plus amputations that take place each year in the United States alone,” Lavery said. He pointed out that diabetic neuropathy often makes it nearly impossible for patients to feel the inflammation that precedes ulceration, and that a thermal sensor gives patients “a way to participate in their own preventive care.”

Don Lawson, CEO of Xilas, told Medical Device Daily that the predicate for the TempTouch is the Dermatemp, made by Exergen (Watertown, Massachusetts). He said that the temperature difference between feet is a very reliable sign that “you have a hot spot, but without such a device, patients may not know that they have a problem until they have an open wound” because of neuropathy. He said that a lot of the available data suggests that inflammation usually precedes the opening of a wound by 10 to 20 days.

At present, the TempTouch is available only by prescription, but that situation might not hold permanently.

“When we submitted our 510(k), we elected to set it up as an Rx device because we felt that it’s important that an individual interacts with their physician regarding their condition. We want them to stay in touch with their doctors,” Lawson said.

On the other hand, Xilas also wanted to ensure that the device would be used properly before trying to go over-the-counter (OTC).

“We’ve invested a lot of time and money in educating physicians at trade shows and via peer-reviewed publications,” he said. “They tend to be a very skeptical group, and rightly so” because it is impossible to predict how a device will be used by a patient, and a doctor’s guidance will help ensure that the first wave of use is appropriate.

As for the date of an OTC application to the FDA, Lawson said he was not certain when that might happen.

No device is perfect, and this includes the TempTouch.

Lawson acknowledged as much but said that the device is accurate to within one degree Fahrenheit. The test of both feet is designed to close any error gap as well as errors of interpretation.

“Feet are cooler in the morning, and no two people have the same foot temperature,” he pointed out

To date, Xilas has sold about 10,000 units, most to disease management customers operating in Texas, Tennessee and New York.

“We found a nice niche with disease management companies,” said Lawson. “Once they’ve learned about the device, they incorporate it into their protocols” for overall reduction of cost of care of diabetes.

Still, the firm wants to market to individuals in the months ahead.

“Our objective is to get the device to individuals. Because of the focus that Medicare and private payers have put on disease management companies, that’s a nice vehicle for us, but ultimately, there may be a time when our sales may be more driven toward individuals.”

To do this, Xilas needs to pin down across-the-board reimbursement because, at the device’s current price of $150, the company needs to obtain reimbursement coding. Lawson declined to predict when Xilas will nail down such a code but said that when it happens, it will “open the door to more sales directly to the individual.”

Onward to Europe for Xilas, Lawson said.

“We’re getting the CE mark, and we’ll have that in early 2007, but we’re going to stay focused on the U.S. for now. We may start to look for [European] distributors in a year or two.”

As for Asia, Lawson reminded: “We’re a small company with limited resources, so we won’t [tackle Asian markets] in the next year or two.”

Xilas is currently privately held, but that may change. “My background,” Lawson said, “is taking companies public, but we do not have any immediate plans at this point.”