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Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01954901
Recruitment Status : Terminated (Failure to enroll subjects due to change in referral policy.)
First Posted : October 7, 2013
Last Update Posted : November 6, 2015
Information provided by (Responsible Party):
David Grant U.S. Air Force Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Wagner Grade 2 Lower Extremity Ulcers Procedure: Hyperbaric oxygen therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers: a Double-blind, Randomized,Controlled Clinical Trial.
Study Start Date : October 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Standard treatment plus HBOT
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.
Procedure: Hyperbaric oxygen therapy
Placebo Comparator: Standard treatment with placebo 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.
Procedure: Hyperbaric oxygen therapy

Primary Outcome Measures :
  1. Changes in wound size - wounds measured by length, width and depth [ Time Frame: 14 months ]
  2. Number of wounds healed [ Time Frame: 14 months ]
  3. Number of major and minor amputations [ Time Frame: Three Years after initiation of study ]

Secondary Outcome Measures :
  1. Peri-wound TCOM values [ Time Frame: 14 months ]
  2. Recurrence of ulceration [ Time Frame: 14 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age equal to or greater than 18.
  2. Type 1 or 2 diabetes mellitus.
  3. 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).
  4. DoD Beneficiary.

Exclusion Criteria:

  1. Impending/urgent amputation due to ongoing or exacerbated infection.
  2. Exposed bone or deep structures.
  3. Severe depression.
  4. Claustrophobia.
  5. Seizure disorder.
  6. Uncontrolled asthma/severe COPD with pCO2 > 45 mmHg on arterial blood gas.
  7. Grade 4 congestive heart failure.
  8. Unstable angina.
  9. Chronic/acute otitis media/sinusitis.
  10. Major tympanic membrane trauma.
  11. Prior chemotherapy with Bleomycin and evidence of deterioration in diffusing capacity after a single hyperbaric oxygen exposure.
  12. 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.
  13. 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.
  14. Women who are breast feeding or of childbearing potential.
  15. Dementia or mental disability rendering the potential subject incapable of following instructions or consenting to treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01954901

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United States, California
David Grant USAF Medical Center
Travis AFB, California, United States, 94535
Sponsors and Collaborators
David Grant U.S. Air Force Medical Center

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Responsible Party: David Grant U.S. Air Force Medical Center Identifier: NCT01954901     History of Changes
Other Study ID Numbers: FDG20120029H
First Posted: October 7, 2013    Key Record Dates
Last Update Posted: November 6, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
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Leg Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases