****The Effect of Monochromatic Infrared Energy on Transcutaneous Oxygen Measurements and Protective Sensation: Results of a C
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Participants. Using convenience sampling methods, adults with diabetes were recruited via word of mouth, diabetic support group lectures, flyers displayed throughout the hospital, press releases, and a newspaper advertisement. Eighteen adults with diabetes participated in this study conducted at the Norwalk Hospital Wound Care and Hyperbaric Medicine Center in Norwalk, Conn. The inclusion criteria included self-reported diabetes with LOPS on each foot and the ability to complete the study protocol for all active/sham MIRE treatments and all pre- and posttest visits. Loss of protective sensation was determined at the pretest visit using the 5.07 SWM according to National Institute of Diabetes and Digestive and Kidney Disease guidelines.21 Persons were excluded if they had a history of lower extremity amputations, cancer, or MIRE treatments. Persons with active malignancy, who were pregnant or breast-feeding, undergoing dialysis, and unable to comfortably lay supine for TcPO2 testing or provide informed consent also were not eligible to participate. Because one purpose of this study was to determine the effect of MIRE on LOPS, persons also were excluded if the pretest sensation assessment did not reveal LOPS on each foot and if the initial TcPO2 was less than 10 mm Hg20,22 — the latter stipulation to ensure TcPO2 results would be within the literature-supported variation.20 For the current study, this would indicate a 12.4 mm Hg, day-to-day variation for a baseline of 40 mm Hg.
Procedures. During the pretest, participants provided informed consent and their recent caffeine, nicotine, and medication use was reported. Years since onset of diabetes mellitus was recorded and participants were asked to rate their pain from 0 to 10 (0 = no pain and 10 = the worst possible pain) for each foot separately. Sensation testing was performed by one investigator using a 5.07 (10-g) SWM randomly at five locations on the plantar aspect of each foot: the first and fourth toes and the first, third, and fifth metatarsal head areas. Sensation testing was performed in a quiet room with no distractions. Participants saw and touched the SWM before testing and then were asked to close their eyes and say “yes” or “now” when they felt a touch and describe the location on which foot the sensation occurred.
Participants found to have LOPS on each foot then rested for approximately 15 minutes, lying supine on a stretcher while their skin was prepared for TcPO2 pre-testing. Pre-testing was performed on two standard test sites per bare foot14: the dorsal first-second distal metatarsal area and the proximal dorsal lateral mid-foot. Per manufacturer protocol,13-16 each subject’s skin was shaved with a safety razor if needed, cleansed well with alcohol wipes, then pressed several times with silk tape to remove excess dry epidermal cells to improve electrode adhesiveness. Electrode fixation rings were applied to the skin at the test sites and drops of contact fluid were applied per manufacturer guidelines. The electrodes were attached after the Radiometer (Copenhagen, Denmark) TCM400 machine was calibrated for use with each patient. The TCM400 machine is a computerized model that automatically calibrates to barometric pressure and 44° C. (The manufacturer donated the TCM400 machine with four electrodes, membranes, and fixation rings for the duration of this study.) A clinic temperature of 68° to 72° F was maintained for all pre- and posttest visits.
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