Foot thermometer helps prevent diabetic ulcers
A digital foot thermometer used in the home can help people with diabetes check for "hot spots" on the soles of their feet.
The portable device monitors foot temperature fluctuations, which commonly occur before ulcers break through the skin.
The TempTouch probe is curved to facilitate contact with the bottom of the feet.
Photo courtesy of Xilas Medical Inc.
How the TempTouch® thermometer works
The TempTouch thermometer is used to take foot temperatures once or twice daily by touching the infrared sensor tip to specific points on the bottom of the feet. The readings are recorded by the patient in a daily logbook.
There is early warning that an ulcer may be developing if the temperature of one foot is significantly greater than the other.[1] Should this occur, individuals are advised to contact a health professional and take pressure off the foot or reduce their activity levels until the temperature difference falls below 2.2oC.
Who might benefit
The number of Canadians with diabetes is expected to reach three million by the end of the decade.[2] Foot ulcers develop in up to 15% of adults who have diabetes. Peripheral neuropathy, present in 60% of those with diabetes, confers the greatest risk of foot ulceration; microvascular disease and suboptimal blood sugar control also contribute. About 12% of those who develop diabetic ulcers will eventually require amputation, with almost half being amputations of the leg.[3]
Regulatory Approval
San Antonio, Texas manufacturer, Xilas Medical Inc., received US Food and Drug Administration marketing approval for the TempTouch infrared foot thermometer in March 2005.[4] The device is not licensed by Health Canada.
Cost
TempTouch is sold by prescription in the US for US$150.[5]
Evidence of efficacy
In two randomized, single-blind trials, patients at high risk of diabetes complications, who used TempTouch for six months, developed fewer complications than those who did not monitor foot temperature.[1,6] One of the 41 patients who used TempTouch developed diabetic foot complications compared with nine from the 44 patients in the standard care group.[1]
In the second study, 180 patients were followed for 15 months.[6] Patients using TempTouch developed significantly fewer foot ulcers (8.5%) than those who had standard care (29.3%) or those who performed a structured foot evaluation twice daily in addition to receiving standard therapy (30.4%).
Future developments
Xilas Medical Inc. is undertaking clinical trials with TempTouch RM®, a device that individuals stand on like a bathroom scale.[7] The device measures and records foot temperatures and the patient's weight before transmitting the information by the Internet to the doctor's office.
References
[1] Lavery LA, et al. Diabetes Care 2004; 27(11):2642. Available: http://care.diabetesjournals.org.
[2] The prevalence and costs of diabetes. Toronto: Canadian Diabetes Association; 2004. Available: http://www.diabetes.ca/Section_about/prevalence.asp.
[3] Stillman RM. Diabetic ulcers E Medicine; 2005 Mar 22. Available: http://www.emedicine.com/med/topic551.htm.
[4] Xilas Medical, Inc. receives 510(k) clearance from FDA for its TempTouch® home temperature monitoring device [news release]. San Antonio (TX): Xilas Medical, Inc; 2005 Mar 30. Available: http://www.xilas.com/pressreleases/30march2005.pdf.
[5] Xilas' TempTouch® home temperature monitoring device now available to diabetic foot consumers [news release]. San Antonio (TX): Xilas Medical, Inc; 2005 Jul 11. Available: http://www.xilas.com/pressreleases/11july2005.pdf.
[6] Xilas Medical, Inc. - clinical trial findings and conclusions. San Antonio (TX): Xilas Medical, Inc; 2005 Jul 11. Available: http://www.xilas.com/clinicaltrials.pdf.
[7] Xilas Medical Inc. receives Phase II funding from the National Institutes of Health for diabetes telemedicine grant [news release]. San Antonio (TX): Xilas Medical, Inc; 2005 Apr 4. Available: http://www.xilas.com/pressreleases/4april2005.pdf.