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Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers

NCT01954901 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-04-17

No results posted yet for this study

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

Interventions

DEVICE

Hyperbaric oxygen therapy

DEVICE

Hyperbaric room air

Sponsors & Collaborators

  • David Grant U.S. Air Force Medical Center

    lead FED

Principal Investigators

  • John B Slade, MD · David Grant Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-08-31
Completion
2015-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01954901 on ClinicalTrials.gov