Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers

• Male and female patients 20-90 years of age with type 1 or type 2 diabetes mellitus with non-healing, full-thickness, University of Texas Classification of Diabetic Foot Ulcers Class IA diabetic foot ulcers of at least 4 weeks duration, but not greater than 52 weeks, measuring 1 -10 cm2 in area (Area = length x width) 50% at least from 65+ age group
• Any diabetic foot ulcer at or below the malleoli
• Patients with partial amputation up to \& including a TMA
• Subjects; between 20-90 years of age with a diabetic foot ulcer; 50% at least from 65+ age group
• Subjects must have had the wound open for at least 4 weeks from day one on screening visit.
• Subjects wound must be ≥1 cm2 in size at screening visit, but not greater than 10 cm2.
• Subject's ABI should be ≥ 0.7 on the study limb or transcutaneous partial pressure oxygen (TcpO2) >40mmHg; or a toe pressure ≥40mmHg; or a Doppler waveform consistent with adequate flow in the foot(biphasic or triphasic waveforms) at screening
• No active malignancy except non-melanoma skin cancer
• Subject and/or caregiver must be willing and able to learn and perform the duties of dressing changes, and demonstrate the ability to do so.
• If patient has had a history of alcohol or substance abuse within 6 months prior to base line period, should provide proof of treatment.

Exclusion Criteria:

• Wounds of duration >52 weeks
• 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;
• Subjects with infected target ulcers, accompanied by cellulitis, known or suspected osteomyelitis, or other clinical evidence of infection;
• Index ulcer has exposed tendons, ligaments, muscle, or bone.
• ulcers present in between toes
• Target limb is infected at beginning of study
• Must never have had malignancy on study limb
• Oral, or IV antibiotic/antimicrobial agents or medications have been used within 2 days (48 hours) of baseline.
• Patients with steroids >7mg dosage are excluded
• Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of screening date.
• Subject may not be pregnant at the time of treatment.
• Subjects with ulcer that has a total Surface Area of greater than 10 cm2 at Screening Visit as measured by a member of the study staff;
• Subject is undergoing renal dialysis, has known immune insufficiency, other than Diabetes Mellitus
• Ulcers which decrease in area by >30% during the screening 1-week run-in period
• History of peripheral vascular repair within the 30 days of baseline.
• Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
• No known "patient-reported" alcohol or substance abuse within three months prior to baseline.
• Subject currently enrolled or participated within 30 days of baseline in another investigational device, drug or biological trial.
• Subject allergic to a broad spectrum of primary \& secondary dressing materials,including occlusive dressings and the adhesives on such dressings.
• Subject with Chopart amputation