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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
HBOT was carried out in a hyperbaric chamber for 120-min per session, five days a week for four consecutive weeks (20 treatment sessions).
wound healing
The Wagner Ulcer Grade Classification System for wound physiological index
Time frame: 4 weeks
inflammation index
Erythrocyte sedimentation rate, ESR; C-reactive protein, CRP
Time frame: 4 weeks
amputation rate
Number of patients undergo surgical removal of a limb
Time frame: 4 weeks
survival rate of tissue in the affected limb
blood flow perfusion scan
Time frame: 4 weeks
bacteriological wound cultures
collect and culture bacteria from the wound to see whether a wound is infected, to identify the bacteria causing the infection
Time frame: 4 weeks
glycemic control
Glycated Hemoglobin, HbA1c Hemoglobin, HbA1c
Time frame: 4 weeks
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