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Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers

Sponsor
David Grant U.S. Air Force Medical Center (U.S. Fed)
Overall Status
Terminated
CT.gov ID
NCT01954901
Collaborator
(none)
2
Enrollment
1
Location
2
Arms
22
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Hyperbaric oxygen therapy
  • Device: Hyperbaric room air
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers: a Double-blind, Randomized,Controlled Clinical Trial.
Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Aug 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Standard treatment plus Hyperbaric Oxygen

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
Placebo Comparator: Standard treatment with 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.

Device: Hyperbaric room air

Outcome Measures

Primary Outcome Measures

  1. Changes in wound size - wounds measured by length, width and depth [14 months]

  2. Number of wounds healed [14 months]

  3. Number of major and minor amputations [Three Years after initiation of study]

Secondary Outcome Measures

  1. Peri-wound TCOM values [14 months]

  2. Recurrence of ulceration [14 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 David Grant USAF Medical Center Travis Air Force Base California United States 94535

Sponsors and Collaborators

  • David Grant U.S. Air Force Medical Center

Investigators

  • Principal Investigator: John B Slade, MD, David Grant Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Grant U.S. Air Force Medical Center
ClinicalTrials.gov Identifier:
NCT01954901
Other Study ID Numbers:
  • FDG20120029H
First Posted:
Oct 7, 2013
Last Update Posted:
Apr 17, 2020
Last Verified:
Apr 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Leg Ulcer
Ulcer

Study Results

No Results Posted as of Apr 17, 2020