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| Name | Class |
|---|---|
| I-Shou University | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hyperbaric oxygen therapy | Experimental | 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). |
|
| Control | No Intervention | The control group received only routine care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric oxygen therapy | Device | HBOT was carried out in a hyperbaric chamber for 120-min per session, five days a week for four consecutive weeks (20 treatment sessions). |
|
| Measure | Description | Time Frame |
|---|---|---|
| wound healing | The Wagner Ulcer Grade Classification System for wound physiological index | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| inflammation index | Erythrocyte sedimentation rate, ESR; C-reactive protein, CRP | 4 weeks |
| amputation rate | Number of patients undergo surgical removal of a limb |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chen-Yu Chen, Master | Chang Gung Memorial Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003920 | Diabetes Mellitus |
| D007249 | Inflammation |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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|
| 4 weeks |
| survival rate of tissue in the affected limb | blood flow perfusion scan | 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 | 4 weeks |
| glycemic control | Glycated Hemoglobin, HbA1c Hemoglobin, HbA1c | 4 weeks |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |