Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: TCO2-2012-01 A Prospective, Randomized, Double-Blind Multicenter Study Comparing Continuous Diffusion of Oxygen (CDO) Therapy to Standard Moist Wound Therapy (MWT) in the Treatment of Complete (100%) wound closure defined as complete re-epithelialization without drainage before or at week 12



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to 50%, 75% and 100% wound closure [ Time Frame: 12 weeks or wound closure ]
    Time to 50%, 75% and 100% wound closure by using digital photography & computerized planimetric analysis
  • Pain Reduction [ Time Frame: 12 weeks or closure ]
    Pain Reduction from day 0 to week 12 or closure using the Wong-Baker Faces™ Pain Rating Scale
  • Quality of Life [ Time Frame: week 12 or wound closure ]
    Quality of Life improvement from day 0 to week 12 or closure using the Diabetic Foot Ulcer Scale - Short form
  • Epithelial tissue development [ Time Frame: week 12 or wound closure ]
    Epithelial tissue development from day 0 to week 12 or closure using the Bates-Jensen Assessment Tool Score
  • Granulation tissue development [ Time Frame: week 12 or wound closure ]
    Granulation tissue development from day 0 to week 12 or closure using the Bates-Jensen Assessment Tool Score
  • Total Bates-Jensen Wound Assessment Tool Score [ Time Frame: week 12 or wound closure ]
    Total Bates-Jensen Wound Assessment Tool Score from day 0 to week 12 or closure


Original Secondary Outcome: Same as current

Information By: Electrochemical Oxygen Concepts, Inc.

Dates:
Date Received: July 18, 2012
Date Started: April 2012
Date Completion:
Last Updated: February 8, 2017
Last Verified: February 2017