Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers

Inclusion Criteria: * Subject has a documented diagnosis of Diabetes mellitus Type 1 or 2 * Foot ulcer at or below ankle with duration of more than 4 weeks but no longer than 1 year * If the index ulcer is a post amputation wound date of surgery must be \> 30 days * 2 week run in period with less than 30% wound size reduction * University of Texas Grade 1A, 1B, 1C, 1D, 2A, 2B, 2C, or 2D (Appendix I) * Ulcer is ≥ 1cm2 and ≤ 20cm2 after debridement at start of run-in period * If more than one ulcer is present on the foot, only the largest is considered in the study (Index ulcer) * Index ulcer must be ≥ 1cm away from any other ulcers present on the foot * Adequate perfusion with ABI \> 0.7 And TcpO2 \> 30mmHg OR skin perfusion \> 30mmHG OR Toe pressure \> 30mmHg OR Duplex with biphasic waveforms below the knee * No planned revascularization procedure or vascular surgery within the last/next 30 days * Subject and/or caregiver are willing and able to comply with all specified care and visit requirements * Subject has a reasonable expectation of completing the study; according to the Investigator's clinical judgment Exclusion Criteria: * Evidence of gangrene on any part of affected limb * Documented evidence of osteomyelitis on any part of affected limb * Index ulcer has exposed bone * Index ulcer exhibits signs of severe clinical infection that requires hospitalization or immediate surgical intervention * Active Charcot foot on the study limb * Subject participated in another investigational device, drug or biological trial within last 30 days * Uncontrolled diabetes: HbA1c \> 12 % * Renal dialysis or creatinine \> 2.5 * Known immune insufficiency * Chronic steroid use or immunosuppressive agents within the last three (3) months or is anticipated to require them during the course of the study * Active treatment for malignancy (not specific to study limb) * Patient has a Deep Vein Thrombosis within the last 30 days * Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within the screening period * Subject may not be pregnant at the time of treatment