oa Validation Of An Optical Fiber Based Smart Textile: A Clinical Tool For Predicting Diabetic Foot Ulceration

Background: Undetected repeated foot loading and temperature changes during walking in diabetic patients with peripheral neuropathy significantly increases risk of foot ulceration. Early detection of inflammation due to foot temperature and pressure changes from walking has shown to be a potentially effective strategy in prevention of foot ulcers. Therefore, a clinically feasible assessment of these changes is vital to measure pre-ulcerative inflammation and predict DFUs. The current study is aimed to validate effectiveness of an innovative fiber optics embedded smart textile for simultaneous measurement of plantar pressure and temperature. Methods: The study recruited 21 diabetic patients (Age: 57.8±7.9 years, BMI: 31.6±8.0 kg/m2, VPT: 26.8±15 volt, 68% diagnosed with peripheral neuropathy) at high risk for foot ulcers from Wound and Diabetic Foot Center at Hamad Medical Co. Doha. A series of sensors were juxtaposed on the length of an optical fiber integrated in a comfortable sock (Novinoor LLC, IL) for measuring temperature and pressure changes under anatomical regions of the heel, midfoot, 1st and 5th metatarsal heads, and big toe based on changes in wavelength of light. A thermal image was acquired after five-minute temperature acclimation before walking for validating temperature changes. Participants walked 200 steps to induce thermal stress and follow up thermal image was acquired. Participants also wore F-scan insoles (TekScan®Inc) during walk for pressure validation. Results: All the recruited patients perceived the device as comfortable. A significant correlation was observed between both pressure (r=0.67, p<0.05) and temperature (r=0.55, p<0.05) measurements between the sock and the reference systems under different anatomical regions of interest. Conclusion: This study demonstrates the proof of concept for an innovative smart textile in simultaneous assessment of the key parameters associated with risk of foot ulcer in patients with diabetes. Given the correlation values, additional studies will larger sample size is required to further validate and address whether the technology can predict and better manage diabetic foot ulcers. Funding source: NPRP 4-1026-3-277