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Short Duration Hyperbaric Oxygen Therapy to Improve HbA1c, Leukocyte, and Serum Creatinine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03615755
Recruitment Status : Completed
First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Hendry Irawan, Udayana University

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.

Condition or disease Intervention/treatment Phase
Hyperbaric Oxygen Therapy Diabetic Foot Ulcer Type II Diabetes Mellitus Other: Hyperbaric Oxygen Therapy (HBOT) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : December 27, 2016
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard Therapy
Standard Therapy (controlling blood sugar, antibiotic drug, ulcer debridement, wound care, offloading)
Active Comparator: Combination Therapy
Standard Therapy with adjuvant Hyperbaric Oxygen Therapy (Total 10 sessions, each session used pressure 2.4 ATA for 90 minutes per day)
Other: 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.




Primary Outcome Measures :
  1. HbA1c levels [ Time Frame: 2 weeks ]
    HbA1c levels test before the patients were done debridement (baseline) and after 2 weeks therapy.

  2. Leukocyte count [ Time Frame: 2 weeks ]
    Leukocyte count test before the patients were done debridement (baseline) and after 2 weeks therapy.

  3. Serum creatinine [ Time Frame: 2 weeks ]
    Serum creatinine levels test before the patients were done debridement (baseline) and after 2 weeks therapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Study Documents (Full-Text)

Documents provided by Hendry Irawan, Udayana University:
Study Protocol  [PDF] April 10, 2018
Statistical Analysis Plan  [PDF] April 10, 2018
Informed Consent Form  [PDF] April 10, 2018


Publications:
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.
World Health Organization. Global status report on noncommunicable diseases 2010. Switzerland: WHO Press; 2011.
World Health Organization. Global Report on Diabetes. Switzerland: WHO Press; 2016.
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.
Flood MS. Hyperbaric Oxygen Therapy for diabetic Foot Ulcers. The Journal of Lancaster General Hospital. 2007;2:140-145.
El-Kader SMA, Ashmawy EM. Impact of Different Therapeutic Modalities on Healing of Diabetic Foot Ulcers. Eur J Gen Med. 2015;12:319-325.
Gupta SK, Sharma AK. Effects of hyperbaric oxygen therapy on haematological and biochemical parameters. Ind J Aerospace Med. 2000;44:1-5.
Irawan H, Kartika. Terapi Oksigen Hiperbarik sebagai Terapi Adjuvan Kaki Diabetik. Cermin Dunia Kedokteran-245. 2016;43:782-785.
Mathieu D, Wattel F. Physiologic Effects of Hyperbaric Oxygen on Microorganisms and Host Defences Against Infection. In: Mathieu D, editor. Handbook on Hyperbaric Medicine. Netherlands: Springer; 2006. p.103-119.
Wibowo A. Oksigen Hiperbarik: Terapi Percepatan Penyembuhan Luka. JuKe Unila. 2015;5:124-128.
Kevin T. Pengaruh Terapi Oksigen Hiperbarik Terhadap eGFR berdasarkan Formula MDRD pada pasien Luka Kaki Diabetik (skripsi). Surabaya: Universitas Katolik Widya Mandala; 2015.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hendry Irawan, Clinical Research, Udayana University
ClinicalTrials.gov Identifier: NCT03615755    
Other Study ID Numbers: HBOT_DFU
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hendry Irawan, Udayana University:
Hyperbaric Oxygen Therapy
Diabetic Foot Ulcer
HbA1c
Leukocyte
Serum creatinine
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetes Mellitus, Type 2
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Glucose Metabolism Disorders
Metabolic Diseases