Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by David Grant U.S. Air Force Medical Center
Sponsor:
Information provided by (Responsible Party):
David Grant U.S. Air Force Medical Center
ClinicalTrials.gov Identifier:
NCT01954901
First received: September 27, 2013
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Wagner Grade 2 Lower Extremity Ulcers
Procedure: Hyperbaric oxygen therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers: a Double-blind, Randomized,Controlled Clinical Trial.

Resource links provided by NLM:


Further study details as provided by David Grant U.S. Air Force Medical Center:

Primary Outcome Measures:
  • Changes in wound size - wounds measured by length, width and depth [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Number of wounds healed [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Number of major and minor amputations [ Time Frame: Three Years after initiation of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peri-wound TCOM values [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Recurrence of ulceration [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 112
Study Start Date: October 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01954901

Contacts
Contact: John Slade, MD 707-423-3987
Contact: Eduardo Sevilla 707-423-7263

Locations
United States, California
David Grant USAF Medical Center Recruiting
Travis AFB, California, United States, 94535
Principal Investigator: John Slade, MD         
Sponsors and Collaborators
David Grant U.S. Air Force Medical Center
  More Information

No publications provided

Responsible Party: David Grant U.S. Air Force Medical Center
ClinicalTrials.gov Identifier: NCT01954901     History of Changes
Other Study ID Numbers: FDG20120029H
Study First Received: September 27, 2013
Last Updated: December 23, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 23, 2014