Monochromatic infrared energy has been reported to restore protective sensation by increasing circulation. A controlled, double-blind, quasi-experimental, randomized clinical study was conducted to 1) examine the effects of monochromatic infrared energy treatments on tissue perfusion, 2) determine the effects of a published monochromatic infrared energy neuropathy protocol on sensation on the feet of patients with diabetes and a loss of protective sensation; 3) examine monochromatic infrared energy's effect on pain; and 4) examine the relationship between transcutaneous oxygen levels and loss of protective sensation. The study was conducted at a wound and hyperbaric treatment center in Norwalk, Conn; 18 adults (12 men, six women; mean age 65 +/-13 years, range 39 to 86 years) with diabetes and loss of protectivesensation were recruited using convenience sampling methods. All patients served as their own control. Pre- and post treatment tests assessed sensation, pain, and transcutaneous oxygen measurements on two sites per foot. Participants underwent a series of 30-minute monochromatic infrared energy treatments (one foot active treatment, one foot sham). Monochromatic infrared energy was delivered at the manufacturer pre-set level of energy of 1.5 J/cm(2)/min at a wavelength of 890 nm; sham units delivered no energy. Scores were analyzed using paired t-tests and Pearson's correlation coefficient. No significant differences were observed between active and sham treatments for transcutaneous oxygen values, pain, or sensation. Both active and sham monochromatic infrared energy-treated feet had significantly improved sensation when compared to pretest baseline scores (P <0.05). No statistical relationship was found between transcutaneousoxygen and sensation. This small study did not demonstrate any effects of monochromatic infrared energy treatment on transcutaneousoxygen measurements, pain, or sensation in adults with diabetes and loss of protective sensation.