Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers
Public ClinicalTrials.gov record NCT02326337. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-national, Multi-center, Prospective, Randomized, Double Blinded, Placebo-controlled Trial to Evaluate the Efficacy of HyperBox Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Diabetic Foot Ulcers
Study identification
- NCT ID
- NCT02326337
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Lead sponsor
- AOTI Ltd.
- Industry
- Enrollment
- 73 participants
Conditions and interventions
Conditions
Interventions
- TWO2 Device Device
- Placebo Device Device
Device
Eligibility (public fields only)
- Age range
- 18 Years to 89 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2014
- Primary completion
- Feb 4, 2018
- Completion
- Oct 24, 2018
- Last update posted
- Oct 26, 2025
2014 – 2018
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Carl T. Hayden VA Medical Center | Phoenix | Arizona | 85012 | — |
| NorthBay Center for Wounds | Vacaville | California | 95687 | — |
| Washington DC VA Medical Center | Washington D.C. | District of Columbia | 20422 | — |
| The Research Center Inc. | Hialeah | Florida | 33013 | — |
| Advanced Research Institute of Miami | Miami | Florida | 33012 | — |
| Advanced Research Institute of Miami | Miami | Florida | 33134 | — |
| Edward Hines, Jr. VA Hospital | Chicago | Illinois | 60141 | — |
| Advanced Foot & Ankle Center | Las Vegas | Nevada | 89119 | — |
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | — |
| Salem VA Medical Center | Salem | Virginia | 24153 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02326337, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 26, 2025 · Synced Jul 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02326337 live on ClinicalTrials.gov.