A Prospective, Randomized, Double-Blind Multicenter Study Comparing Continuous Diffusion of Oxygen (CDO) Therapy to standard Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Ulcers
This is a multicenter, prospective, parallel, double-blinded, validation study of up to 12 weeks duration to evaluate the safety and effectiveness of CDO for the treatment of Diabetic Foot Ulcers at over 30 centers in the United States. The primary objectives of this study are: 1) to evaluate the effectiveness of CDO in combination with standard MWT on wound healing as compared to standard MWT alone; and 2) screening for potential safety issues. The CDO study device is the TransCu O2® (EO2 Concepts, San Antonio, TX), a Class II medical device which has US Food and Drug Administration (FDA) 510(k) clearance, CE-Mark approval and a Health Canada license for the treatment of DFUs as well as other wound types. Diabetic subjects with a Diabetic Foot Ulcer present for a minimum of 30 days will be enrolled. All subjects enrolled in the study will receive a standard wound therapy regimen consisting of, wound cleansing, moist wound care, off-loading and as appropriate, aggressive debridement. Subjects will be randomized to either the Treatment arm or the Control arm. Subjects will be assessed weekly for signs of wound healing during the 12-week Treatment Period, and once at the end of 12-week Durability Period.