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Oxygen therapy shows promise for stubborn diabetic foot sores

NCT ID NCT02326337

Disease control Sponsor: AOTI Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device that delivers oxygen directly to chronic diabetic foot ulcers to help them heal. 73 people with diabetes and foot sores that had not healed for over a month took part. Half used the real oxygen device, and half used a fake device, while all received standard wound care. The main goal was to see if the oxygen therapy could close the wound within 12 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

73 people

The number who actually took part.

Started

Oct 2014

Finished

Oct 2018

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 89 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject has a documented diagnosis of Diabetes mellitus Type 1 or 2 * Foot ulcer at or below ankle with duration of more than 4 weeks but no longer than 1 year * If the index ulcer is a post amputation wound date of surgery must be \> 30 days * 2 week run in period with less than 30% wound size reduction * University of Texas Grade 1A, 1B, 1C, 1D, 2A, 2B, 2C, or 2D (Appendix I) * Ulcer is ≥ 1cm2 and ≤ 20cm2 after debridement at start of run-in period * If more than one ulcer is present on the foot, only the largest is considered in the study (Index ulcer) * Index ulcer must be ≥ 1cm away from any other ulcers present on the foot * Adequate perfusion with ABI \> 0.7 And TcpO2 \> 30mmHg OR skin perfusion \> 30mmHG OR Toe pressure \> 30mmHg OR Duplex with biphasic waveforms below the knee * No planned revascularization procedure or vascular surgery within the last/next 30 days * Subject and/or caregiver are willing and able to comply with all specified care and visit requirements * Subject has a reasonable expectation of completing the study; according to the Investigator's clinical judgment Exclusion Criteria: * Evidence of gangrene on any part of affected limb * Documented evidence of osteomyelitis on any part of affected limb * Index ulcer has exposed bone * Index ulcer exhibits signs of severe clinical infection that requires hospitalization or immediate surgical intervention * Active Charcot foot on the study limb * Subject participated in another investigational device, drug or biological trial within last 30 days * Uncontrolled diabetes: HbA1c \> 12 % * Renal dialysis or creatinine \> 2.5 * Known immune insufficiency * Chronic steroid use or immunosuppressive agents within the last three (3) months or is anticipated to require them during the course of the study * Active treatment for malignancy (not specific to study limb) * Patient has a Deep Vein Thrombosis within the last 30 days * Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within the screening period * Subject may not be pregnant at the time of treatment

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Conditions

The condition(s) this trial relates to.

Diabetic Foot

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic foot ulcer

Contacts and locations

Locations

  • Advanced Foot & Ankle Center

    Las Vegas, Nevada, 89119, United States

  • Advanced Research Institute of Miami

    Miami, Florida, 33012, United States

  • Advanced Research Institute of Miami

    Miami, Florida, 33134, United States

  • Avicenne Hospital

    Bobigny, 93000, France

  • Carl T. Hayden VA Medical Center

    Phoenix, Arizona, 85012, United States

  • Edward Hines, Jr. VA Hospital

    Chicago, Illinois, 60141, United States

  • Hospital Simone Veil

    Eaubonne, 95600, France

  • Hunter Holmes McGuire VA Medical Center

    Richmond, Virginia, 23249, United States

  • King's College Hospital

    London, SE5 9RS, United Kingdom

  • Kirchberg Hospital

    Luxembourg, L-2540, Luxembourg

  • Montpellier University Hospital

    Montpellier, 34000, France

  • NorthBay Center for Wounds

    Vacaville, California, 95687, United States

  • Northwick Park Hospital

    Harrow, HA1 3UJ, United Kingdom

  • Salem VA Medical Center

    Salem, Virginia, 24153, United States

  • Städtisches Klinikum Dessau

    Dessau, 06847, Germany

  • The Research Center Inc.

    Hialeah, Florida, 33013, United States

  • Washington DC VA Medical Center

    Washington D.C., District of Columbia, 20422, United States

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