Short Duration Hyperbaric Oxygen Therapy to Improve HbA1c, Leukocyte, and Serum Creatinine
NCT ID: NCT03615755
Last Updated: 2020-05-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-12-27
Study Completion Date
2017-03-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Hyperbaric Oxygen Therapy
Diabetic Foot Ulcer
Type II Diabetes Mellitus
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Standard Therapy
Standard Therapy (controlling blood sugar, antibiotic drug, ulcer debridement, wound care, offloading)
Group Type
NO_INTERVENTION
No interventions assigned to this group
Combination Therapy
Standard Therapy with adjuvant Hyperbaric Oxygen Therapy (Total 10 sessions, each session used pressure 2.4 ATA for 90 minutes per day)
Group Type
ACTIVE_COMPARATOR
Hyperbaric Oxygen Therapy (HBOT)
Intervention Type
OTHER
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.
Interventions
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Hyperbaric Oxygen Therapy (HBOT)
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.
Intervention Type
OTHER
Eligibility Criteria
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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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hendry Irawan
OTHER
Sponsor Role
lead
Responsible Party
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Hendry Irawan
Clinical Research
Responsibility Role
SPONSOR_INVESTIGATOR
References
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Kementerian Kesehatan Republik Indonesia. Diabetes Melitus Penyebab Kematian Nomor 6 di Dunia: Kemenkes Tawarkan Solusi Cerdik Melalui Posbind. (online) 2013 Sep. [cited 2016 Aug. 30] Available from: http://www.depkes.go.id/article/print/2383/diabetes-melitus-penyebab-kematian-nomor-6-di-dunia-kemenkes-tawarkan-solusi-cerdik-melalui-posbindu.html.
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BACKGROUND
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World Health Organization. Global Report on Diabetes. Switzerland: WHO Press; 2016.
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BACKGROUND
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Wounds International. International Best Practice Guidelines: Wound Management in Diabetic Foot Ulcers. London: Wounds International A division of Schofield Healthcare Media Limited Enterprise House; 2013.
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BACKGROUND
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BACKGROUND
Aydin F, Kaya A, Karapinar L, Kumbaraci M, Imerci A, Karapinar H, Karakuzu C, Incesu M. IGF-1 Increases with Hyperbaric Oxygen Therapy and Promotes Wound Healing in Diabetic Foot Ulcers. J Diabetes Res. 2013;2013:567834. doi: 10.1155/2013/567834. Epub 2013 Feb 26.
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El-Kader SMA, Ashmawy EM. Impact of Different Therapeutic Modalities on Healing of Diabetic Foot Ulcers. Eur J Gen Med. 2015;12:319-325.
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Al-Waili NS, Butler GJ, Beale J, Abdullah MS, Finkelstein M, Merrow M, Rivera R, Petrillo R, Carrey Z, Lee B, Allen M. Influences of hyperbaric oxygen on blood pressure, heart rate and blood glucose levels in patients with diabetes mellitus and hypertension. Arch Med Res. 2006 Nov;37(8):991-7. doi: 10.1016/j.arcmed.2006.05.009.
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Ayvaz S, Aksu B, Kanter M, Uzun H, Erboga M, Colak A, Basaran UN, Pul M. Preventive effects of hyperbaric oxygen treatment on glycerol-induced myoglobinuric acute renal failure in rats. J Mol Histol. 2012 Apr;43(2):161-70. doi: 10.1007/s10735-012-9391-5. Epub 2012 Feb 7.
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Irawan H, Semadi IN, Widiana IGR. A Pilot Study of Short-Duration Hyperbaric Oxygen Therapy to Improve HbA1c, Leukocyte, and Serum Creatinine in Patients with Diabetic Foot Ulcer Wagner 3-4. ScientificWorldJournal. 2018 Aug 12;2018:6425857. doi: 10.1155/2018/6425857. eCollection 2018.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HBOT_DFU
Identifier Type: -
Identifier Source: org_study_id
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