Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers

Not Applicable

Terminated

• Conditions: Wagner Grade 2 Lower Extremity Ulcers
• Interventions: Device: Hyperbaric oxygen therapy; Device: Hyperbaric room air

• Registration Number: NCT01954901
• Lead Sponsor: David Grant U.S. Air Force Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-27
• Study First Submitted QC: 2013-09-27
• Study Start: 2013-10
• Study First Posted: 2013-10-07
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-16
• Last Update Posted: 2020-04-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard treatment plus Hyperbaric Oxygen	Hyperbaric oxygen therapy	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.
Standard treatment with Hyperbaric Room Air	Hyperbaric room air	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.

Primary Outcome Measures

Name	Time	Method
Number of wounds healed	14 months
Number of major and minor amputations	Three Years after initiation of study
Changes in wound size - wounds measured by length, width and depth	14 months

Secondary Outcome Measures

Name	Time	Method
Recurrence of ulceration	14 months
Peri-wound TCOM values	14 months

Trial Locations

Locations (1)

David Grant USAF Medical Center; 🇺🇸 Travis Air Force Base, California, United States