Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers

NCT01954901 | Terminated DMC FDA Device

• 1 other identifier: FDG20120029H
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Wagner Grade 2 Lower Extremity Ulcers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Peri-wound TCOM values

  14 months

• Recurrence of ulceration

  14 months

Study Arms (2)

Standard treatment plus Hyperbaric Oxygen

EXPERIMENTAL

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

Standard treatment with Hyperbaric Room Air

PLACEBO COMPARATOR

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

Interventions

Hyperbaric oxygen therapy DEVICE

Standard treatment plus Hyperbaric Oxygen

Hyperbaric room air DEVICE

Standard treatment with Hyperbaric Room Air

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• David Grant U.S. Air Force Medical Center: lead

Study Sites (1)

David Grant USAF Medical Center

Travis Air Force Base, California, 94535, United States

Location

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• John B Slade, MD

  David Grant Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2013
• First Posted: October 7, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 17, 2020

Record last verified: 2020-04

Locations

US (1)