Hyperbaric Oxygen Therapy in Diabetics With Chronic Foot Ulcers and Improvement of Quality of Life

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Hyperbaric Oxygen Therapy in Diabetics With Chronic Foot Ulcers and Improvement of Quality of Life

Conditions
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Diabetic Foot Ulcer, Diabetes

Intervention / Treatment
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* Device: Hyperbaric oxygen therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hyperbaric oxygen therapy<br>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<br>* HBOT was carried out in a hyperbaric chamber for 120-min per session, five days a week for four consecutive weeks (20 treatment sessions).<br>* Other names: HBOT;|
| No Intervention: Control<br>The control group received only routine care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound healing | The Wagner Ulcer Grade Classification System for wound physiological index | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperbaric oxygen therapy, diabetic foot ulcer, wound healing, inflammation, glycemic control, amputation, bacterial infection, quality of life