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Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers

Primary Purpose

Wagner Grade 2 Lower Extremity Ulcers

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hyperbaric oxygen therapy

Hyperbaric room air

About this trial

This is an interventional treatment trial for Wagner Grade 2 Lower Extremity Ulcers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

David Grant USAF Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Standard treatment plus Hyperbaric Oxygen

Standard treatment with Hyperbaric Room Air

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes in wound size - wounds measured by length, width and depth

Number of wounds healed

Number of major and minor amputations

Secondary Outcome Measures

Peri-wound TCOM values

Recurrence of ulceration

Full Information

NCT ID

NCT01954901

First Posted

September 27, 2013

Last Updated

April 16, 2020

Sponsor

David Grant U.S. Air Force Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01954901

Brief Title

Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers

Official Title

Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers: a Double-blind, Randomized,Controlled Clinical Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Terminated

Why Stopped

Failure to enroll subjects due to change in referral policy.

Study Start Date

October 2013 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

David Grant U.S. Air Force Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wagner Grade 2 Lower Extremity Ulcers

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard treatment plus Hyperbaric Oxygen

Arm Type

Experimental

Arm Description

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.

Arm Title

Standard treatment with Hyperbaric Room Air

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Hyperbaric oxygen therapy

Intervention Type

Device

Intervention Name(s)

Hyperbaric room air

Primary Outcome Measure Information:

Title

Changes in wound size - wounds measured by length, width and depth

Time Frame

14 months

Title

Number of wounds healed

Time Frame

14 months

Title

Number of major and minor amputations

Time Frame

Three Years after initiation of study

Secondary Outcome Measure Information:

Title

Peri-wound TCOM values

Time Frame

14 months

Title

Recurrence of ulceration

Time Frame

14 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John B Slade, MD

Organizational Affiliation

David Grant Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

David Grant USAF Medical Center

City

Travis Air Force Base

State/Province

California

ZIP/Postal Code

94535

Country

United States

12. IPD Sharing Statement

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Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers

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