Hyperbaric Oxygen Therapy in Diabetics With Chronic Foot Ulcers and Improvement of Quality of Life
NCT ID: NCT02328508
Last Updated: 2014-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
38 participants
INTERVENTIONAL
2011-06-30
2013-06-30
Brief Summary
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Detailed Description
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RESEARCH DESIGN AND METHODS - This study was a randomized, single-center clinical trial. The effects of HBOT on patients in the experimental group were compared with the control group received only routine care. HBOT was carried out in a hyperbaric chamber for 120-min per session, five days a week for four consecutive weeks (20 treatment sessions). Data were collected at 4 segments: pre-treatment (before first administration of HBOT; T1), during treatment (at the tenth administration of HBOT; T2), post-treatment (at the twentieth administration of HBOT; T3), and treatment follow-up (two weeks after the last therapy ended; T4).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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hyperbaric oxygen therapy
The experimental group received treatments in a hyperbaric chamber for 120-min per session, once per day, and five days per week for four consecutive weeks (20 treatment sessions).
Hyperbaric oxygen therapy
HBOT was carried out in a hyperbaric chamber for 120-min per session, five days a week for four consecutive weeks (20 treatment sessions).
Control
The control group received only routine care.
No interventions assigned to this group
Interventions
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Hyperbaric oxygen therapy
HBOT was carried out in a hyperbaric chamber for 120-min per session, five days a week for four consecutive weeks (20 treatment sessions).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* a history of diabetes and a diagnosis of diabetic foot
* a wound classification of Grade 3 or below
* clear conscious and willing to participate in this study
* a signed consent form
Exclusion Criteria
20 Years
ALL
No
Sponsors
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I-Shou University
OTHER
Chen-Yu Chen
OTHER
Responsible Party
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Chen-Yu Chen
Registered Nurse
Principal Investigators
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Chen-Yu Chen, Master
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Other Identifiers
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100-0876B, 101-0507C
Identifier Type: -
Identifier Source: org_study_id