| 124 |
Clinical Research
|
HYPERSPECTRAL IMAGING TO MONITOR DIABETIC FOOT ULCERS First Author: Jenny Freeman MD Authors: Aristidis Veves MD, Beth Israel Deaconess Medical Center, Aksone Nouvong MD, UCLA David Geffen School of Medicine, Svetlana Panasyuk PhD, HyperMed Inc., Kevin Schomacker PhD, HyperMed Inc. INTRODUCTION: The purpose is to evaluate Hyperspectral Transcutaneous Oxygen Monitoring (HTcOM) in the prediction of diabetic foot ulceration and the assessment of diabetic foot ulcers and wound healing in 2 longitudinal studies. MATERIALS AND METHODS: A multi-center study has an ulcer healing arm collecting measurements from 66 type 1 and 2 diabetics with at least one foot ulcer. Tissue bordering existing ulcers is measured at 11 visits over 6 months and HTcOM measurements correlated with wound healing. The ulcer prediction arm surveys feet of 210 type 1 and 2 high risk diabetic subjects over an 18 month period. Quantitative measures of oxyhemoglobin (HT-Oxy) and deoxyhemoglobin (HT-Deoxy) are extracted from the hyperspectral data and used as the primary endpoint for deciding the state of the tissue. RESULTS: This report provides combined data from Phase 1 and Phase 2 NIH/NIDDK studies. Interim data reflects 35 subjects enrolled in the ulcer study and 73 subjects in the ulcer prediction study with many subjects having data for at least 3 months. HT-Oxy/HT-Deoxy pairs range from 38 ± 2/26±3, 50±3/49±2 and 62±4/71±4 (mean±SE) for non healing ulcers, healing ulcers and feet without ulcers, respectively. A negative HT-healing index, calculated from HT-Oxy/HT-Deoxy pairs, denotes ulcers unlikely to heal with sensitivity and specificity of 93% and 86%. A preliminary HT-Prediction Index, also calculated from the HT-Oxy/HT-Deoxy pairs has been developed to predict areas at risk for ulceration as well as previously healed ulcer areas at risk for recurrence. DISCUSSION: HTcOM provides a local assessment of tissue oxygenation status, providing for the first time an anatomically relevant metric of the capability of an existing ulcer to heal and of defining tissue at risk for ulceration from a single patient visit. HTcOM information may be used in the 3 main areas of patient care: prevention, anatomic diagnosis and monitoring of therapy. |
|