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
Phase: NA
Conditions: Hyperbaric Oxygen Therapy, Diabetic Foot Ulcer, Type II Diabetes Mellitus
Sponsor: Hendry Irawan

Original Article NCT03615755 
 
 
Short Duration Hyperbaric Oxygen Therapy to Improve HbA1c, Leukocyte, and Serum 
Creatinine in Patient with Diabetic Foot Ulcer Wagner 3-4 
 
 
Author: 
dr. Hendry Irawan 
Surgery Department, Faculty of Medicine, Udayana University, Sanglah General Hospital, 
Denpasar, Indonesia. 
 
 
Co-Author 1: 
Dr. dr. I Nyoman Semadi, Sp.B, Sp.BTKV 
Thorax and Cardiovascular Surgery Division, Surgery Department, Faculty of Medicine, 
Udayana University, Sanglah General Hospital, Denpasar, Indonesia. 
 
 
Co-Author 2: 
Prof. Dr. dr. I Gde Raka Widiana, Sp.PD-KGH 
Nephrology and Hypertension Division, Internal Medicine Department, Faculty of Medicine, 
Udayana University, Sanglah General Hospital, Denpasar, Indonesia. 
 
 
Correspondence: 
Name            :   dr. Hendry Irawan 
Phone            :   +62 82125097786 
Email            :   hendry_irawan@rocketmail.com 
Affiliation     :   Surgery Department, Faculty of Medicine, Udayana University, Sanglah 
General Hospital, Denpasar, Indonesia. 
Address         :   Kesehatan Street No. 1, Denpasar, Bali, Indonesia. 
 
 
 
 
 
Denpasar, 10-04-2018 
 
dr. Hendry Irawan

Methods 
 
This study uses pretest and posttest control group design, to know the role of 
standard therapy and combination therapy (standard therapy with adjuvant HBOT) to 
decrease HbA1c levels, leukocyte count, and serum creatinine levels in DFU patient 
Wagner 3-4. All DM 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 they are willing to participate in the study and use 
HBOT was grouped to combination therapy, if they are willing to participate in the study 
but do not want to use HBOT was grouped to standard therapy, but if they are not willing 
participate then excluded. The study was approved by Institutional Review Board of 
Medical Faculty of Udayana University    and    Sanglah    General    Hospital    Denpasar    
with    the    ethical    number 
580/UN.14.2/KEP/2016. 
 
Thirty diabetic patients with DFU Wagner 3-4 were participated in this study. 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 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, IL, 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.