Wagner Grade 2 Lower Extremity Ulcers
Conditions
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.
Interventions
DEVICEHyperbaric oxygen therapy
DEVICEHyperbaric room air
Sponsors
David Grant U.S. Air Force Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Peri-wound TCOM values | 14 months |
| Recurrence of ulceration | 14 months |
Countries
United States
Outcome results
None listed