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