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 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