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

NCT03615755 | Completed

• 1 other identifier: HBOT_DFU
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperbaric Oxygen Therapy; Diabetic Foot Ulcer; Type II Diabetes Mellitus

Keywords

Hyperbaric Oxygen Therapy; Diabetic Foot Ulcer; HbA1c; Leukocyte; Serum creatinine

Outcome Measures

Primary Outcomes (3)

• HbA1c levels

  HbA1c levels test before the patients were done debridement (baseline) and after 2 weeks therapy.

  2 weeks

• Leukocyte count

  Leukocyte count test before the patients were done debridement (baseline) and after 2 weeks therapy.

  2 weeks

• Serum creatinine

  Serum creatinine levels test before the patients were done debridement (baseline) and after 2 weeks therapy.

  2 weeks

Study Arms (2)

Standard Therapy

NO INTERVENTION

Standard Therapy (controlling blood sugar, antibiotic drug, ulcer debridement, wound care, offloading)

Combination Therapy

ACTIVE COMPARATOR

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)

Interventions

Hyperbaric Oxygen Therapy (HBOT) 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.

Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• patients who had severe organs dysfunction such as heart failure, pulmonary infection, pneumothorax, chronic obstructive pulmonary disease, and stroke.

Sponsors & Collaborators

• Hendry Irawan: lead

Related Publications (33)

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  BACKGROUND

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  BACKGROUND

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  PMID: 23162231 BACKGROUND

• Karadurmus N, Sahin M, Tasci C, Naharci I, Ozturk C, Ilbasmis S, Dulkadir Z, Sen A, Saglam K. Potential benefits of hyperbaric oxygen therapy on atherosclerosis and glycaemic control in patients with diabetic foot. Endokrynol Pol. 2010 May-Jun;61(3):275-9.

  PMID: 20602302 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.

  PMID: 23671876 BACKGROUND

• El-Kader SMA, Ashmawy EM. Impact of Different Therapeutic Modalities on Healing of Diabetic Foot Ulcers. Eur J Gen Med. 2015;12:319-325.

  BACKGROUND

• Gupta SK, Sharma AK. Effects of hyperbaric oxygen therapy on haematological and biochemical parameters. Ind J Aerospace Med. 2000;44:1-5.

  BACKGROUND

• 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.

  PMID: 17045116 BACKGROUND

• Nwafor TS, Collins N. Managing low blood glucose levels in patients undergoing hyperbaric oxygen therapy. Ostomy Wound Manage. 2014 Apr;60(4):12-5. No abstract available.

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  PMID: 22269009 BACKGROUND

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• Kevin T. Pengaruh Terapi Oksigen Hiperbarik Terhadap eGFR berdasarkan Formula MDRD pada pasien Luka Kaki Diabetik (skripsi). Surabaya: Universitas Katolik Widya Mandala; 2015.

  BACKGROUND

• 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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• Berkovitch M, Tsadik R, Kozer E, Abu-Kishk I. The effect of hyperbaric oxygen therapy on kidneys in a rat model. ScientificWorldJournal. 2014;2014:105069. doi: 10.1155/2014/105069. Epub 2014 Aug 10.

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  PMID: 24634591 BACKGROUND

• 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.

  PMID: 30158840 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus, Type 2

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 6, 2018
• Study Start: December 27, 2016
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: May 4, 2020

Record last verified: 2020-05