NCT00871312

Evaluation of Topical Wound Oxygen (two2) Therapy

A Randomized, Double-blinded, Parallel Group, Placebo-Controlled, Multi-Center Trial of Topical Wound Oxygen Therapy in the Treatment of Diabetic Lower Extremity Ulcers

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: AOTI Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the efficacy of the Topical Wound Oxygen (two2) therapy system on the healing of diabetic lower extremity ulcers.

Detailed description

The AOTI two2 therapy trial is a randomized, double-blinded, parallel group, placebo-controlled, multi-center study intended to evaluate the efficacy of Topical Wound Oxygen (two2) therapy in relation to placebo when added to standard of care in the treatment of diabetic lower extremity ulcers.

Conditions

• Diabetic Ulcer

Interventions

Type	Name	Description
DEVICE	Topical wound oxygen therapy	90 minutes 4 days per week Active Topical Oxygen Therapy
DEVICE	Topical wound oxygen Placebo	90 mins per day 4 days per week Placebo Therapy

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-03-30
• Last updated: 2014-01-10

Locations

3 sites across 2 countries: United States, Canada