Diabetes, Diabetic Foot Ulcer
Conditions
Keywords
hyperbaric oxygen therapy, diabetic foot ulcer, wound healing, inflammation, glycemic control, amputation, bacterial infection, quality of life
Brief summary
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.
Detailed description
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).
Interventions
DEVICEHyperbaric 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).
Sponsors
I-Shou University
Chen-Yu Chen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* over 20 years of age * 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
* less than 20 years of age, unwilling to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| wound healing | 4 weeks | The Wagner Ulcer Grade Classification System for wound physiological index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| inflammation index | 4 weeks | Erythrocyte sedimentation rate, ESR; C-reactive protein, CRP |
| amputation rate | 4 weeks | Number of patients undergo surgical removal of a limb |
| survival rate of tissue in the affected limb | 4 weeks | blood flow perfusion scan |
| bacteriological wound cultures | 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 | 4 weeks | Glycated Hemoglobin, HbA1c Hemoglobin, HbA1c |
Outcome results
None listed