(WHS-K1.03) A disposable device for fast screening of diabetic foot ulcer infection
Thursday, May 16, 2024
9:15 AM – 10:15 AM East Coast USA Time
Purpose: The initial identification of infection in DFU mostly depends on the clinical signs and symptoms of local inflammation. The wound specimens are then collected via wound swab or tissue biopsy for microbiological analysis. Unfortunately, many infected wounds present subtle or no signs and symptoms of infection. Thus, there is an urgent need for the development of a complimentary approach or device that can quickly screen and identify suspected infection in DFU. Recent study shows that infected wounds have elevated leukocyte esterase (LE) activities as compared with non-infected wounds by a portable device - Detec® Esterase. Here, we try to answer two questions. Are LE activities elevated in wound fluids isolated from infected DFU wounds compared to those from non-infected wounds? Can Detec® Esterase be used to screen infection of DFU at point-of-care?
Method: Wound dressings from 15 infected DFU wounds and 5 non-infected DFU wounds based on the culture results were isolated for LE activities measurement. Dressings from 20 DFU patients (14 infected and 6 non-infected) at the Texas Health Arlington Memorial Wound Care and Limb Salvage Clinic were tested with DETEC® esterase and the device output was compared with subsequent clinical determination of infection on the same wounds. We evaluated the efficiency of the device through sensitivity, specificity, accuracy, and the increase in post-test risk of infection with positive test result.
Results: Our results show that LE activities are significantly higher in infected DFUs (>0.02794 U/mL) than in non-infected DFUs (0.003902-0.02275 U/mL). By comparing our device output with the clinical determination, our results show that pre-optimized DETEC® Esterase has a high sensitivity (~85.7%) and accuracy (75.0%) for screening infected DFU wounds. Further analyses revealed that the diagnosis accuracy of the device is not influenced by the patients’ age, gender, race, initial wound size, wound location, and sign of infection.
Conclusion: Our results support that LE activities are elevated in infected DFU wounds, and LE may be used as a biomarker for DFU infection. DETEC® esterase can effectively and accurately diagnose and/or screen for infections in DFUs.