A Prospective, Randomized, Double-Blind Multicenter Study Comparing CDO Therapy to Standard MWT in the Treatment of DFUs

Inclusion Criteria: * Subjects 30-90 years of age at the time of Informed Consent * Subjects with type 1 or type 2 Diabetes Mellitus with a non-healing, full-thickness, University of Texas Classification of Diabetic Foot Ulcers Class IA diabetic foot ulcers * Subjects who have an ulcer with a duration of at least 4 weeks, but not greater than 52 weeks at time of screening * Subjects with an index ulcer measuring between 1.5 - 10 cm2 in area after debridement (Area = length x width) at time of Screening 1 and Screening 2, as measured using digital photography \& computerized planimetric analysis by Centralized Wound Measuring Center (CWMC) * Subjects with a diabetic foot ulcer(s) at or below the malleoli * Subjects who demonstrates adequate arterial perfusion defined as either: * transcutaneous oxygen measurements of the dorsum of the foot \> 30 mm Hg with a skin perfusion pressure \> 30 mm Hg, or an ankle/brachial index (ABI) above 0.7, with documented confirmation of adequate arterial perfusion, or * a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms) at screening, or * absolute toe pressure of \> 30 mm Hg * Subject and/or caregiver must be able and willing to learn and perform the duties of dressing changes * Subjects are able and willing to comply with standardized off-loading regimen (such as a fixed ankle walker) Exclusion Criteria: * Subjects \< 30 or \> 90 years of age at the time of Informed Consent * Subjects wi…