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 with Target Ulcers with a duration \< 4 weeks or \> 52 weeks * Subjects with ulcers measuring less than 1.5 cm2 or greater than 10 cm2 in area (Area = length x width) after debridement at the time of Screening 1 and Screening 2 to Randomization) or \> 50% during the 2 week screening period, as measured using digital photography \& computerized planimetric analysis's determined by CWMC. * Subjects whose ulcer decreased in area by \> 30 % during the 1 week screening period * Subjects with evidence of gangrene on any part of affected limb * Subjects with active Charcot's foot on the study limb * Subjects scheduled to undergo vascular surgery, angioplasty or thrombolysis at the time of enrollment * Subjects with active infection at the time of screening * Subjects with a target ulcer which has exposed tendons, ligaments, muscle, or bone * Subjects with active malignancy, excluding non-melanoma skin cancer * Subjects with a history of malignancy on study limb * Subjects in whom oral, or IV antibiotic/antimicrobial agents or medications have been used within 2 days (48 hours) of baseline * Subjects who are currently receiving or has received radiation or chemotherapy within 3 months of randomization * Subjects who have received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of screening * Subjects who are pregnant at the time of screening * Subjects who are undergoing active renal dialysis * Subjects who have a known immune insufficiency, excluding Diabetes Mellitus * Subjects with a history of peripheral vascular repair within 14 days of screening * Subjects with a current deep vein thrombosis (DVT) * Subjects with ulcers due to Raynaud's disease * Subjects with and ulcer due to acute thrombophlebitis * Subjects with inadequate perfusion to support healing * Subjects with necrotic wounds covered with eschar or slough * Subjects with wounds with fistulae or deep sinus tracts of unknown depth * Subjects who are receiving palliative care * Subjects who have a HbA1c \> 12% (uncontrolled hyperglycemia) * Subjects whose target ulcer has a known etiology of: malignancy, burn, collagen vascular disease, sickle cell, vasculopathy, or pyoderma gangrenosum * Subjects with a documented history of alcohol or substance abuse within 6 months of screening * Subjects who are currently enrolled or who have participated, within 30 days of screening, in another investigational device, drug or biological trial that may interfere with study results * Subjects with a known allergy to dressing materials, including occlusive dressings and the adhesives on such dressings