A Prospective, Randomized, Double-Blind Multicenter Study Comparing Continuous Diffusion of Oxygen (CDO) Therapy to Standard Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Ulcers

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic Foot Ulcer Read More

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 - 10 cm2 in area after debridement (Area = length x width)
• 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 < 30 or > 90 years of age at the time of Informed Consent

  • Subjects with Target Ulcers with a duration < 4 weeks or > 52 weeks
  • Subjects with ulcers measuring less than 1 cm2 or greater than 10 cm2 in area (Area = length x width) after debridement at the time of screening
  • 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 may interfere with study results
  • Subjects with a known allergy to dressing materials, including occlusive dressings and the adhesives on such dressings