Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers

David Grant U.S. Air Force Medical Center

Status: Terminated

Conditions: Wagner Grade 2 Lower Extremity Ulcers

Treatments: Device: Hyperbaric oxygen therapy; Device: Hyperbaric room air

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01954901

FDG20120029H

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2 participants in 2 patient groups, including a placebo group

Standard treatment plus Hyperbaric Oxygen

Experimental group

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.

Treatment:

Device: Hyperbaric oxygen therapy

Standard treatment with Hyperbaric Room Air

Placebo Comparator group

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.

Treatment:

Device: Hyperbaric room air