Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers

Study Overview
=================
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.

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

Conditions
-----------------
Wagner Grade 2 Lower Extremity Ulcers

Intervention / Treatment
-----------------
* Device: Hyperbaric oxygen therapy
* Device: Hyperbaric room air


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard treatment plus Hyperbaric Oxygen<br>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. | Device: Hyperbaric oxygen therapy<br> <br> |
| Placebo Comparator: Standard treatment with Hyperbaric Room Air<br>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. | Device: Hyperbaric room air<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in wound size - wounds measured by length, width and depth |  | 14 months | 
| Number of wounds healed |  | 14 months | 
| Number of major and minor amputations |  | Three Years after initiation of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-wound TCOM values |  | 14 months | 
| Recurrence of ulceration |  | 14 months |