Short Duration Hyperbaric Oxygen Therapy to Improve HbA1c, Leukocyte, and Serum Creatinine
Primary Purpose
Hyperbaric Oxygen Therapy, Diabetic Foot Ulcer, Type II Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hyperbaric Oxygen Therapy (HBOT)
Sponsored by
About this trial
This is an interventional supportive care trial for Hyperbaric Oxygen Therapy focused on measuring Hyperbaric Oxygen Therapy, Diabetic Foot Ulcer, HbA1c, Leukocyte, Serum creatinine
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard Therapy
Combination Therapy
Arm Description
Standard Therapy (controlling blood sugar, antibiotic drug, ulcer debridement, wound care, offloading)
Standard Therapy with adjuvant Hyperbaric Oxygen Therapy (Total 10 sessions, each session used pressure 2.4 ATA for 90 minutes per day)
Outcomes
Primary Outcome Measures
HbA1c levels
HbA1c levels test before the patients were done debridement (baseline) and after 2 weeks therapy.
Leukocyte count
Leukocyte count test before the patients were done debridement (baseline) and after 2 weeks therapy.
Serum creatinine
Serum creatinine levels test before the patients were done debridement (baseline) and after 2 weeks therapy.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03615755
Brief Title
Short Duration Hyperbaric Oxygen Therapy to Improve HbA1c, Leukocyte, and Serum Creatinine
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 27, 2016 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hendry Irawan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperbaric Oxygen Therapy, Diabetic Foot Ulcer, Type II Diabetes Mellitus
Keywords
Hyperbaric Oxygen Therapy, Diabetic Foot Ulcer, HbA1c, Leukocyte, Serum creatinine
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Therapy
Arm Type
No Intervention
Arm Description
Standard Therapy (controlling blood sugar, antibiotic drug, ulcer debridement, wound care, offloading)
Arm Title
Combination Therapy
Arm Type
Active Comparator
Arm Description
Standard Therapy with adjuvant Hyperbaric Oxygen Therapy (Total 10 sessions, each session used pressure 2.4 ATA for 90 minutes per day)
Intervention Type
Other
Intervention Name(s)
Hyperbaric Oxygen Therapy (HBOT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
HbA1c levels
Description
HbA1c levels test before the patients were done debridement (baseline) and after 2 weeks therapy.
Time Frame
2 weeks
Title
Leukocyte count
Description
Leukocyte count test before the patients were done debridement (baseline) and after 2 weeks therapy.
Time Frame
2 weeks
Title
Serum creatinine
Description
Serum creatinine levels test before the patients were done debridement (baseline) and after 2 weeks therapy.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Short Duration Hyperbaric Oxygen Therapy to Improve HbA1c, Leukocyte, and Serum Creatinine
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