Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers

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

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

    • California
      • Travis Air Force Base, California, United States, 94535
        • David Grant USAF Medical Center

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:

  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. Severe depression.
  3. Claustrophobia.
  4. Seizure disorder.
  5. Uncontrolled asthma/severe COPD with pCO2 > 45 mmHg on arterial blood gas.
  6. Grade 4 congestive heart failure.
  7. Unstable angina.
  8. Chronic/acute otitis media/sinusitis.
  9. Major tympanic membrane trauma.
  10. Prior chemotherapy with Bleomycin and evidence of deterioration in diffusing capacity after a single hyperbaric oxygen exposure.
  11. 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.
  12. 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.
  13. Women who are breast feeding or of childbearing potential.
  14. 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.
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.

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
Three Years after initiation of study

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

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.

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