Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers

Wagner Grade 2 Lower Extremity Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01954901
• Other study ID #: FDG20120029H
• Status: Terminated
• Phase: N/A
• Start date: October 2013
• Est. completion date: August 2015

Study information

• Verified date: April 2020
• Source: David Grant U.S. Air Force Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Wagner Grade 2 Lower Extremity Ulcers

Intervention

Device:
• Hyperbaric oxygen therapy

• Hyperbaric room air

Locations

Country	Name	City	State
United States	David Grant USAF Medical Center	Travis Air Force Base	California

Sponsors (1)

Lead Sponsor	Collaborator
David Grant U.S. Air Force Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in wound size - wounds measured by length, width and depth		14 months
Primary	Number of wounds healed		14 months
Primary	Number of major and minor amputations		Three Years after initiation of study
Secondary	Peri-wound TCOM values		14 months
Secondary	Recurrence of ulceration		14 months