Wagner Grade 2 Lower Extremity UlcersNCT01954901
Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers
A study testing Hyperbaric oxygen therapy and Hyperbaric room air in people with Wagner Grade 2 Lower Extremity Ulcers, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
Trial summary
The purpose of this proposed DoD study is to determine if hyperbaric oxygen therapy (HBOT) plus standard wound care is more effective than standard wound care alone in the rate of healing and prevention of major amputation (metatarsal and proximal) in Wagner grade 2 diabetic lower extremity ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wagner Grade 2 Lower Extremity Ulcers
- What is being tested?
- Hyperbaric oxygen therapy and Hyperbaric room air
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age equal to or greater than 18.
- Type 1 or 2 diabetes mellitus.
- Wagner Grade 2 wound for at least 4 weeks. A diagnosis of a Wagner Grade 2 wound necessitates a persistent wound of 4 weeks (5).
- DoD Beneficiary.
Who cannot join
- Impending/urgent amputation due to ongoing or exacerbated infection.
- Severe depression.
- Claustrophobia.
- Seizure disorder.
- Uncontrolled asthma/severe COPD with pCO2 > 45 mmHg on arterial blood gas.
- Grade 4 congestive heart failure.
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- Unstable angina.
- Chronic/acute otitis media/sinusitis.
- Major tympanic membrane trauma.
- Prior chemotherapy with Bleomycin and evidence of deterioration in diffusing capacity after a single hyperbaric oxygen exposure.
- Candidates for vascular surgery/angioplasty/stenting or patients with major large vessel disease. These patients could have peripheral vascular disease of such severity that hyperbaric treatment would not improve their condition.
- Vascular surgery/angioplasty within the last 3 months. This exclusion controls for improvements to a patients vasculature and perfusion that occur within 1-2 months after vascular surgery/angioplasty. This will ensure that any perfusion changes to the patient's diabetic wound ulcer area recorded during the study are a result of hyperbaric therapy instead of recent vascular procedures.
- Women who are breast feeding or of childbearing potential.
- Dementia or mental disability rendering the potential subject incapable of following instructions or consenting to treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
David Grant USAF Medical Center
Travis Air Force Base, California, 94535
About this study
Official title: Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers: a Double-blind, Randomized,Controlled Clinical Trial.
The purpose of this proposed DoD study is to determine if hyperbaric oxygen therapy (HBOT) plus standard wound care is more effective than standard wound care alone in the rate of healing and prevention of major amputation (metatarsal and proximal) in Wagner grade 2 diabetic lower extremity ulcers.
- Conditions
- Wagner Grade 2 Lower Extremity Ulcers
- Being tested
- Hyperbaric oxygen therapy, Hyperbaric room air
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapyDevice
Hyperbaric room airDevice
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment plus Hyperbaric Oxygen | Experimental | The study treatment group will be compressed on air in the hyperbaric chamber to 2.0 atmospheres absolute (ATA), then placed on 100% oxygen by a head tent for 90 minutes. Receives: Device: Hyperbaric oxygen therapy |
| Standard treatment with Hyperbaric Room Air | Placebo comparator | The study control group will be compressed to 2.0 ATA on air, then breath 21% oxygen and 79% nitrogen through the hood for 90 minutes. Receives: Device: Hyperbaric room air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in wound size - wounds measured by length, width and depth
Measured: 14 months
Number of wounds healed
Measured: 14 months
Number of major and minor amputations
Measured: Three Years after initiation of study
Secondary outcomes (2)
Peri-wound TCOM values
Measured: 14 months
Recurrence of ulceration
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Failure to enroll subjects due to change in referral policy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wagner Grade 2 Lower Extremity UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Grant U.S. Air Force Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- John B Slade, MD, Principal investigator, David Grant Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954901
- Sponsor's protocol ID
- FDG20120029H
- Status last verified
- Apr 2020
- First submitted
- 27 Sep 2013
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers: a Double-blind, Randomized,Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT01954901
- Acronym / sponsor ID
- FDG20120029H
- Conditions
- Wagner Grade 2 Lower Extremity Ulcers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to enroll subjects due to change in referral policy.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- David Grant U.S. Air Force Medical CenterUS federal agency
- Study start
- Oct 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 7 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this proposed DoD study is to determine if hyperbaric oxygen therapy (HBOT) plus standard wound care is more effective than standard wound care alone in the rate of healing and prevention of major amputation (metatarsal and proximal) in Wagner grade 2 diabetic lower extremity ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment plus Hyperbaric Oxygen | Experimental | Device: Hyperbaric oxygen therapyThe study treatment group will be compressed on air in the hyperbaric chamber to 2.0 atmospheres absolute (ATA), then placed on 100% oxygen by a head tent for 90 minutes. |
| Standard treatment with Hyperbaric Room Air | Placebo comparator | Device: Hyperbaric room airThe study control group will be compressed to 2.0 ATA on air, then breath 21% oxygen and 79% nitrogen through the hood for 90 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age equal to or greater than 18.
- Type 1 or 2 diabetes mellitus.
- Wagner Grade 2 wound for at least 4 weeks. A diagnosis of a Wagner Grade 2 wound necessitates a persistent wound of 4 weeks (5).
- DoD Beneficiary.
Key exclusion criteria (14 listed)
- Impending/urgent amputation due to ongoing or exacerbated infection.
- Severe depression.
- Claustrophobia.
- Seizure disorder.
- Uncontrolled asthma/severe COPD with pCO2 > 45 mmHg on arterial blood gas.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen therapy | Device | Standard treatment plus Hyperbaric Oxygen |
| Hyperbaric room air | Device | Standard treatment with Hyperbaric Room Air |
Primary outcome
Changes in wound size - wounds measured by length, width and depth
Time frame: 14 months
Number of wounds healed
Time frame: 14 months
Number of major and minor amputations
Time frame: Three Years after initiation of study
2 secondary outcomes
Peri-wound TCOM values
Time frame: 14 months
Recurrence of ulceration
Time frame: 14 months
Results and safety
The study was stopped early (reason given: Failure to enroll subjects due to change in referral policy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John B Slade, MD principal investigator
David Grant Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric oxygen therapy and Hyperbaric room air in people with Wagner Grade 2 Lower Extremity Ulcers, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Failure to enroll subjects due to change in referral policy.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in wound size - wounds measured by length, width and depth (time frame: 14 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.