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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
Hendry Irawan
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 9, 2018
    Last Updated
    May 1, 2020
    Sponsor
    Hendry Irawan
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    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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