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 Diabetic

Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of Continuous Diffusion of Oxygen (CDO) therapy for the treatment of Diabetic Foot Ulcers. The primary objective of this study is to evaluate the effectiveness of CDO in combination with standard moist wound therapy (MWT) on wound healing as compared to standard MWT alone.

Detailed Summary:
Sponsor: Electrochemical Oxygen Concepts, Inc.

Current Primary Outcome: Complete (100%) wound closure defined as complete re-epithelialization without drainage [ Time Frame: 12 weeks or wound closure ]

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