The TempTouch^® Dermal Thermometer is an infrared thermometer intended for the intermittent measurement of skin surface temperature. The current use of this device is for temperature observation and comparison of both feet in individuals with diabetes for the purpose of identifying increased skin temperatures, intended as an early warning of inflammation, impending infection and possible foot ulceration.

Investigational and Not Medically Necessary:

The use of TempTouch^® Dermal Thermometer is considered investigational and not medically necessary.

Studies were found that examined the relationship of increased skin temperatures with skin ulceration of the feet in diabetics with peripheral neuropathy or a history of previous foot ulceration.

Armstrong and colleagues (1997) conducted a retrospective study of diabetics (n=143) to compare skin temperatures in individuals with asymptomatic peripheral sensory neuropathy, neuropathic ulcers, and Charcot's arthropathy. The participants were divided into three groups: subjects with asymptomatic sensory neuropathy (n=78), subjects with neuropathic foot ulcers (n = 44), and subjects with neuropathic fractures (Charcot's arthropathy) (n=21). Skin temperatures were measured with a portable hand-held infrared skin temperature probe at the time pathology was initially identified and at subsequent clinical visits for an average of 22.1 months (SD =6.4). Skin temperatures of the contralateral foot were measured as a control. There were differences in skin temperature between the affected foot and the contralateral foot among the subjects with Charcot's arthropathy (8.3 degrees F) and the subjects with neuropathic ulcers (5.6 degrees F), with no difference identified among the subjects with asymptomatic sensory neuropathy. Five subjects with neuropathic ulcers experienced reulceration a mean of 12.2 months (SD=6.4) after initial healing, with a corresponding increase in skin temperature (89.6 degrees +/- 1.2 degrees F versus 82.5 degrees +/- 2.9 degrees F) at the clinic visit immediately preceding reinjury. The data suggest that monitoring skin temperatures of the corresponding contralateral foot site may provide clinical information before other clinical signs of injury can be identified. 

Lavery and colleagues (2007) conducted a physician blinded, randomized, 15 month, multicenter trial of 173 subjects with diabetes and a previous history of diabetic foot ulceration. Study participants were assigned to standard therapy (n=58), structured foot examination (n=56), or enhanced therapy groups (n=59). Each group received therapeutic footwear, diabetic foot education and regular foot care. Subjects in the structured foot examination group performed a structured foot inspection daily and recorded their findings in a logbook. If standard therapy or structured foot examinations identified any foot abnormalities, subjects were instructed to contact the study nurse immediately. Subjects in the enhanced therapy group used an infrared skin thermometer to measure temperatures on six foot sites each day. Temperature differences greater than 4°F (2.2°C) between left and right corresponding sites triggered subjects to contact the study nurse and reduce activity until temperatures normalized. The enhanced therapy group had fewer foot ulcers than the standard therapy and structured foot examination groups (enhanced therapy 8.5% vs. standard therapy 29.3%, P= 0.0046 and enhanced therapy vs. structured foot examination 30.4%, P= 0.0029). Subjects in the standard therapy and structured foot examination groups were 4.37 and 4.71 times more likely to develop ulcers than those in the enhanced therapy group.

Armstrong and colleagues (2007) conducted a study to evaluate the effectiveness of home temperature monitoring to reduce the incidence of foot ulcers in high-risk diabetics. This physician-blinded, 18-month randomized controlled trial enrolled 225 subjects with diabetes at high risk for ulceration who were assigned to standard therapy (Standard Therapy Group) or dermal thermometry (Dermal Thermometry Group) groups. Both groups received therapeutic footwear, diabetic foot education, regular foot care, and performed a structured foot inspection daily. The Dermal Thermometry Group subjects used an infrared skin thermometer to measure temperatures on 6 foot sites twice daily. Temperature differences greater than 4 degrees F between left and right corresponding sites triggered subjects to contact the study nurse and reduce activity until temperatures normalized. A total of 8.4% (n=19) subjects ulcerated over the study period. Subjects were one third as likely to ulcerate in the Dermal Thermometry Group compared with the Standard Therapy Group (12.2% vs. 4.7%, odds ratio 3.0, 95% confidence interval, 1.0 to 8.5, P=.038). Those that ulcerated had a temperature difference (between the affected foot and the same site contralaterally) that was 4.8 times greater in the region of ulceration in the week before ulceration than did a random 7 consecutive-day sample of 50 other subjects that did not ulcerate (3.50+/-1.0 vs. 0.74+/-0.05, P=.001). The authors concluded that high temperature gradients between feet may predict the onset of neuropathic ulceration and self-monitoring may reduce the risk of ulceration.

Based on the available peer reviewed literature, larger studies are required to demonstrate that measuring skin temperature variance in the feet of diabetics can be useful in predicting the most common foot-related complications of diabetes. 

There are approximately 23.6 million Americans with diabetes and many develop foot related problems as a result of the disease. The foot related problems are sometimes referred to as peripheral diabetic neuropathy. The symptoms of neuropathy include numbness and loss of feeling. The exact cause of diabetic neuropathy is not known. Researchers believe that the process of nerve damage is related to high glucose concentrations in the blood that could cause chemical damage to the nerves, disrupting normal neural sensory function. Numbness and loss of feeling in the feet make it difficult for a diabetic to identify a disease process such as infection which could become ulcerated and necrotic if treatment is delayed. Increases in skin temperature may be an early warning for potential infections.

The TempTouch Dermal Thermometer  is a small handheld probe designed for home use. The user places the tip of the device on the skin areas of both feet and temperature measurements are taken automatically. If an increased temperature measurement between corresponding sites of the left and right foot is detected by the thermometer, the users are advised to alter their behavior by reducing activity levels and to contact their health care provider. The TempTouch Dermal Thermometer has received 510k clearance from the United States Food and Drug Administration.

Dermal: Relating to the skin.

Ulceration: A circumscribed inflammatory and often suppurating lesion on the skin or an internal mucous surface resulting in necrosis of tissue.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. 

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Armstrong DG, Holtz-Neiderer K, Wendel C, et al. Skin temperature monitoring reduces the risk for diabetic foot ulceration in high-risk patients. Am J Med. 2007; 120(12):1042-1046.
2. Armstrong DG, Lavery LA, Liswood PJ, et al. Infrared dermal thermometry for the high-risk diabetic foot. Phys Ther. 1997; 77(2):169-175.
3. Armstrong DG, Lavery LA, Wunderlich RP, Boulton AJ. Skin temperatures as a one-time screening tool do not predict future diabetic foot complications. J Am Podiatr Med Assoc. 2003; 93(6):443-447.
4. Armstrong DG, Lipsky BA, Polis AB, Abramson MA. Does dermal thermometry predict clinical outcome in diabetic foot infection? Analysis of data from the SIDESTEP* trial. Wound J. 2006; 3(4):302-307.
5. Lavery LA, Higgins KR, Lanctot DR, et al. Preventing diabetic foot ulcer recurrence in high-risk patients: use of temperature monitoring as a self-assessment tool. Diabetes Care. 2007; 30(1):14-20.
6. Sun PC, Jao SH, Cheng CK. Assessing foot temperature using infrared thermography. Foot Ankle Int. 2005; 26(10):847-853.

Government Agency, Medical Society, and Other Authoritative Publications:

1. U.S. Food and Drug Administration 510(k) Premarket Notification Database. TempTouch^® Dermal Thermometer Summary of Safety and Effectiveness. No. K081162. May 8, 2008. Rockville, MD: FDA. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/K081162.pdf. Accessed June 17, 2011.

1. American Diabetes Association. Available at: http://www.diabetes.org/. Accessed on June17, 2011.
2. Centers for Disease Control and Prevention (CDC). Take Charge of Your Diabetes: Foot Problems. Available at: http://www.cdc.gov/diabetes/pubs/tcyd/foot.htm. Accessed on June17, 2011.

Dermal Thermometer
Infrared Thermometer
Skin Surface Thermometer
TempTouch^® Dermal Thermometer

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.