- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01954901
Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers
April 16, 2020 updated by: David Grant U.S. Air Force Medical Center
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Travis Air Force Base, California, United States, 94535
- David Grant USAF Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Standard treatment plus Hyperbaric Oxygen
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.
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PLACEBO_COMPARATOR: Standard treatment with Hyperbaric Room Air
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in wound size - wounds measured by length, width and depth
Time Frame: 14 months
|
14 months
|
Number of wounds healed
Time Frame: 14 months
|
14 months
|
Number of major and minor amputations
Time Frame: Three Years after initiation of study
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Three Years after initiation of study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peri-wound TCOM values
Time Frame: 14 months
|
14 months
|
Recurrence of ulceration
Time Frame: 14 months
|
14 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: John B Slade, MD, David Grant Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (ACTUAL)
August 1, 2015
Study Completion (ACTUAL)
August 1, 2015
Study Registration Dates
First Submitted
September 27, 2013
First Submitted That Met QC Criteria
September 27, 2013
First Posted (ESTIMATE)
October 7, 2013
Study Record Updates
Last Update Posted (ACTUAL)
April 17, 2020
Last Update Submitted That Met QC Criteria
April 16, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FDG20120029H
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Wagner Grade 2 Lower Extremity Ulcers
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Chongqing Medical UniversityUnknownDiabetic Extremity Lower UlcersChina
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Celleration, Inc.CompletedVenous Insufficiency | Venous Reflux | Lower Extremity UlcerUnited States
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SerenaGroup, Inc.Sanara MedTechActive, not recruiting
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Tampere University HospitalTampere University; Aalto University; Åbo Akademi UniversityCompletedPatients With Lower Extremity Venous Ulcers | Patients With Localized EdemaFinland
-
EnzySurgeCompletedLower Extremity Chronic Venous UlcersIsrael
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MediWound LtdCompletedVenous Leg Ulcers | Hard to Heal Wounds | Diabetic Lower Extremity Ulcers | Traumatic/ Post Operative WoundsIsrael
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Macrocure Ltd.ICON plc; Amarex Clinical Research; ARANZ MedicalCompletedLower Extremity Chronic Ulcers in DiabeticsUnited States, Israel, Canada
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US Department of Veterans AffairsCompletedDiabetes | Amputations | Lower Extremity Ulcers
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Research Center MatrixCompletedChronic Venous Insufficiency | Trophic UlcersRussian Federation
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St. Luke's-Roosevelt Hospital CenterKinetic Concepts, Inc.CompletedVenous Stasis Ulcers | Lower Extremity Wound InfectedUnited States
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