Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers
Public ClinicalTrials.gov record NCT01291160. 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 Prospective, Randomized Blinded Multicenter, Parallel Study Comparing Transdermal, Continuous Oxygen Delivery to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Ulcers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01291160
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 130 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 20 Years to 90 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, 2009
- Primary completion
- Jan 31, 2013
- Completion
- Jan 31, 2013
- Last update posted
- May 12, 2014
2009 – 2013
United States locations
- U.S. sites
- 14
- U.S. states
- 8
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Carl T. Hayden VA Medical Center | Phoenix | Arizona | 85012 | — |
| Southern AZ VA Health Care System | Tucson | Arizona | 85723 | — |
| Dean Vayser, DPM | Encinitas | California | 92024 | — |
| California School of Podiatric Medicine | Fresno | California | 93719 | — |
| Not listed | Los Angeles | California | 90010 | — |
| Not listed | San Jose | California | 95116 | — |
| The Diabetic Foot | San Marcos | California | 92078-2427 | — |
| UF College of Medicine-Jacksonville | Jacksonville | Florida | 32209 | — |
| Bruce W. Carter Dept. of Veterans Affairs Medical Center, Miami VA Health Care System | Miami | Florida | 33125 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Ocean County Foot & Ankle Surgical Associates | Toms River | New Jersey | 08753 | — |
| Ohio College of Podiatric Medicine | Independence | Ohio | 44131 | — |
| Not listed | San Antonio | Texas | 78212 | — |
| Tacoma Diabetic Foot Center | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01291160, 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 May 12, 2014 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01291160 live on ClinicalTrials.gov.