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.

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.