Hyperbaric Oxygen Therapy in Diabetics With Chronic Foot Ulcers and Improvement of Quality of Life
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|ClinicalTrials.gov Identifier: NCT02328508|
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : December 31, 2014
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer Diabetes||Device: Hyperbaric oxygen therapy||Phase 1|
OBJECTIVE - This study evaluated the effect of hyperbaric oxygen therapy (HBOT) on wound healing, inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial wound cultures, and quality of life (QOL) in diabetic foot ulcer (DFU) patients with diabetes.
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hyperbaric Oxygen Therapy in Diabetics With Chronic Foot Ulcers and Improvement of Quality of Life|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Experimental: 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).
Device: 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 Name: HBOT
No Intervention: Control
The control group received only routine care.
- wound healing [ Time Frame: 4 weeks ]The Wagner Ulcer Grade Classification System for wound physiological index
- inflammation index [ Time Frame: 4 weeks ]Erythrocyte sedimentation rate, ESR; C-reactive protein, CRP
- amputation rate [ Time Frame: 4 weeks ]Number of patients undergo surgical removal of a limb
- survival rate of tissue in the affected limb [ Time Frame: 4 weeks ]blood flow perfusion scan
- bacteriological wound cultures [ Time Frame: 4 weeks ]collect and culture bacteria from the wound to see whether a wound is infected, to identify the bacteria causing the infection
- glycemic control [ Time Frame: 4 weeks ]Glycated Hemoglobin, HbA1c Hemoglobin, HbA1c
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328508
|Principal Investigator:||Chen-Yu Chen, Master||Chang Gung Memorial Hospital|