Short Duration Hyperbaric Oxygen Therapy to Improve HbA1c, Leukocyte, and Serum Creatinine

Study Overview
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Brief Summary
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The investigators want to evaluate the short duration HBOT can improve glycohemoglobin (HbA1c) levels, leukocyte count, and serum creatinine levels in patients with DFU (diabetic foot ulcer) Wagner 3-4.

Detailed Description
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This study uses pretest and posttest control group design. All DM (diabetes mellitus) patients with DFU at Sanglah General Hospital, Denpasar who meet the inclusion and exclusion criteria and willing to follow the research procedure. All patients are signing the agreement paper after getting research explanation. All patients were briefed on the study research using HBOT. If the patients are willing to participate in the study and use HBOT was grouped to combination therapy, if the patients are willing to participate in the study but do not want to use HBOT was grouped to standard therapy, but if the patients are not willing participate then excluded. All patients were taken blood test for HbA1c levels, leukocyte count, and serum creatinine levels before debridement, then grouped for standard therapy or standard therapy with 10 sessions of HBOT. One session of HBOT uses oxygen at 2.4 ATA (atmosphere absolute) for 90 minutes per day at multiplace hyperbaric chamber. This therapy is given five sessions in a week, so it takes two weeks. At the end of therapy, all blood tests were performed again in both groups. The inclusion criteria were patients who had type 2 diabetes and DFU Wagner class 3 or 4, aged over 18 years, and underwent debridement with or without toe amputation. The exclusion criteria were patients who had severe organs dysfunction such as heart failure, pulmonary infection, pneumothorax, chronic obstructive pulmonary disease, and stroke. Statistical analysis using SPSS 17.0 (SPSS Inc., Chicago, Illinois, USA). All variables were described before and after treatment. Analysis pretest and posttest values on both groups were used paired T-test and independent T-test. The statistical test results are significant if p < 0.05.

Official Title
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A Pilot Study of Short Duration Hyperbaric Oxygen Therapy to Improve HbA1c, Leukocyte, and Serum Creatinine in Patient With Diabetic Foot Ulcer Wagner 3-4

Conditions
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Hyperbaric Oxygen Therapy, Diabetic Foot Ulcer, Type II Diabetes Mellitus

Intervention / Treatment
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* Other: Hyperbaric Oxygen Therapy (HBOT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who had type 2 diabetes and DFU Wagner class 3 or 4, aged over 18 years, and underwent debridement with or without toe amputation. Exclusion Criteria: patients who had severe organs dysfunction such as heart failure, pulmonary infection, pneumothorax, chronic obstructive pulmonary disease, and stroke.

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Therapy<br>Standard Therapy (controlling blood sugar, antibiotic drug, ulcer debridement, wound care, offloading) | |
| Active Comparator: Combination Therapy<br>Standard Therapy with adjuvant Hyperbaric Oxygen Therapy (Total 10 sessions, each session used pressure 2.4 ATA for 90 minutes per day) | Other: Hyperbaric Oxygen Therapy (HBOT)<br>* The investigators used 10 sessions of HBOT. One session of HBOT uses oxygen at 2.4 ATA for 90 minutes per day at multiplace hyperbaric chamber. This therapy is given five sessions in a week, so it takes two weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c levels | HbA1c levels test before the patients were done debridement (baseline) and after 2 weeks therapy. | 2 weeks | 
| Leukocyte count | Leukocyte count test before the patients were done debridement (baseline) and after 2 weeks therapy. | 2 weeks | 
| Serum creatinine | Serum creatinine levels test before the patients were done debridement (baseline) and after 2 weeks therapy. | 2 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, HbA1c, Leukocyte, Serum creatinine