Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers

Inclusion Criteria:

• Male and female patients 20-90 years of age with type 1 or type 2 diabetes mellituswith non-healing, full-thickness, University of Texas Classification of Diabetic FootUlcers Class IA diabetic foot ulcers of at least 4 weeks duration, but not greaterthan 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 screeningvisit.

• 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 pressureoxygen (TcpO2) >40mmHg; or a toe pressure ≥40mmHg; or a Doppler waveform consistentwith 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 ofdressing changes, and demonstrate the ability to do so.

• If patient has had a history of alcohol or substance abuse within 6 months prior tobase 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 suspectedosteomyelitis, 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 2days (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) withintwo 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 ScreeningVisit as measured by a member of the study staff;

• Subject is undergoing renal dialysis, has known immune insufficiency, other thanDiabetes 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 3months of randomization.

• No known "patient-reported" alcohol or substance abuse within three months prior tobaseline.

• Subject currently enrolled or participated within 30 days of baseline in anotherinvestigational device, drug or biological trial.

• Subject allergic to a broad spectrum of primary & secondary dressingmaterials,including occlusive dressings and the adhesives on such dressings.

• Subject with Chopart amputation