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

Not Applicable

Completed

• Conditions: Type II Diabetes Mellitus; Hyperbaric Oxygen Therapy; Diabetic Foot Ulcer
• Interventions: Other: Hyperbaric Oxygen Therapy (HBOT)

• Registration Number: NCT03615755
• Lead Sponsor: Hendry Irawan

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-12-27
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-08-06
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-01
• Last Update Posted: 2020-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination Therapy	Hyperbaric Oxygen Therapy (HBOT)	Standard Therapy with adjuvant Hyperbaric Oxygen Therapy (Total 10 sessions, each session used pressure 2.4 ATA for 90 minutes per day)

Primary Outcome Measures

Name	Time	Method
Serum creatinine	2 weeks	Serum creatinine levels test before the patients were done debridement (baseline) and after 2 weeks therapy.
HbA1c levels	2 weeks	HbA1c levels test before the patients were done debridement (baseline) and after 2 weeks therapy.
Leukocyte count	2 weeks	Leukocyte count test before the patients were done debridement (baseline) and after 2 weeks therapy.