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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| Background | World Health Organization. Global status report on noncommunicable diseases 2010. Switzerland: WHO Press; 2011. | ||
| 17357221 | Background | Societe de Pathologie Infectieuse de Langue Francaise. Management of diabetic foot infections. Short text. Societe de Pathologie Infectieuse de Langue Francaise. Med Mal Infect. 2007 Jan;37(1):1-25. doi: 10.1016/j.medmal.2006.09.002. No abstract available. English, French. | |
| Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 10, 2018 | May 1, 2020 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 10, 2018 | May 1, 2020 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 10, 2018 | May 1, 2020 | ICF_005.pdf |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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| World Health Organization. Global Report on Diabetes. Switzerland: WHO Press; 2016. |
| 17280936 | Background | Frykberg RG, Zgonis T, Armstrong DG, Driver VR, Giurini JM, Kravitz SR, Landsman AS, Lavery LA, Moore JC, Schuberth JM, Wukich DK, Andersen C, Vanore JV; American College of Foot and Ankle Surgeons. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. 2006 Sep-Oct;45(5 Suppl):S1-66. doi: 10.1016/S1067-2516(07)60001-5. |
| Background | 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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| 23832595 | Background | Jeffcoate WJ, Game FL. Evidence for the use of biological therapies in ulcers of the foot in diabetes. BioDrugs. 2014 Feb;28(1):1-6. doi: 10.1007/s40259-013-0052-3. |
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| 17045116 | 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. |
| 24706399 | 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. |
| 22269009 | Background | Wilkinson D, Chapman IM, Heilbronn LK. Hyperbaric oxygen therapy improves peripheral insulin sensitivity in humans. Diabet Med. 2012 Aug;29(8):986-9. doi: 10.1111/j.1464-5491.2012.03587.x. |
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| Background | 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. |
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| 21717415 | Background | Uzun G, Mutluoglu M, Uz O. Hyperbaric oxygen therapy in diabetic patients - comments on the paper by Karadurmus et al. Endokrynol Pol. 2011;62(3):286-7. No abstract available. |
| 17537119 | Background | Fife CE, Buyukcakir C, Otto G, Sheffield P, Love T, Warriner R 3rd. Factors influencing the outcome of lower-extremity diabetic ulcers treated with hyperbaric oxygen therapy. Wound Repair Regen. 2007 May-Jun;15(3):322-31. doi: 10.1111/j.1524-475X.2007.00234.x. |
| Background | Kevin T. Pengaruh Terapi Oksigen Hiperbarik Terhadap eGFR berdasarkan Formula MDRD pada pasien Luka Kaki Diabetik (skripsi). Surabaya: Universitas Katolik Widya Mandala; 2015. |
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| 30158840 | Derived | 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. |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |