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
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.
Condition:
Hyperbaric Oxygen Therapy
Treatment:
Hyperbaric Oxygen Therapy (HBOT)
Start Date:
December 27, 2016
Sponsor:
Hendry Irawan
For More Information:
https://clinicaltrials.gov/show/NCT03615755