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 90 years of age at the time of Informed Consent
• Subjects with Target Ulcers with a duration 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