NCT01291160

Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers

A Prospective, Randomized Blinded Multicenter, Parallel Study Comparing Transdermal, Continuous Oxygen Delivery to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Ulcers

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Neogenix, LLC dba Ogenix · Industry
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, prospective, parallel, double-blinded, validation study of up to 12 weeks duration to evaluate the safety and effectiveness of EPIFLO for the treatment of Diabetic Foot Ulcer. The primary objectives of this study are: 1) to evaluate the effectiveness of EPIFLO in combination with standard wound therapy on wound healing as compared to standard wound therapy alone; and 2) Screening for potential safety issues. Diabetic subjects with a Diabetic Foot Ulcer present for a minimum of 30 days will be enrolled. All subjects enrolled in the study will receive a standard wound therapy regimen consisting of, wound cleansing, moist wound care, off-loading and as appropriate, aggressive debridement. Subjects will be randomized to either the Treatment arm or the Control arm. Subjects will be assessed weekly for signs of wound healing during the 12-week Treatment Period, once two weeks after wound closure and once at the end of 12-week durability Period.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
DEVICE	Epiflo	During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.
OTHER	Moist Wound Therapy	During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.

Timeline

• Start date: 2009-10-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2011-02-08
• Last updated: 2014-05-13
• Results posted: 2014-05-13

Locations

14 sites across 1 country: United States