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This study seeks to assess changes in genes that are related to inflammation and oxidative stress in patients with type 2 Diabetes with diabetic foot treated with hyperbaric chamber
Aims: Patients with an uncontrolled glycemic index develop a wide variety of pathologies associated with diabetes, such as diabetic foot ulcers (DFUs). Hyperbaric oxygen therapy (HBOT) is an adjunctive therapy used to help wound healing and prevent lower extremity amputations in this population. The aim of this study was to analyze the effect of HBOT on the gene expression of Super Oxide Dismutase 1 (SOD1), Super Oxide Dismutase 2 (SOD2), Glutathione Peroxidase (GPX2), and pro-inflammatory cytokines (TNFα, IL-1β, IL-12, IL-4, NLRP3) in patients with Wagner stage II-IV DFUs.
Methods: The effect of HBOT was evaluated in 15 patients that underwent 12 and 30 sessions in the hyperbaric chamber. Blood samples were collected and relative gene expression was assessed by quantitative real time polymerase chain reaction (qPCR). In the analysis, qualitative variables are presented in frequencies and percentages, compared with the Chi-square test; quantitative variables according to the Shapiro-Wilk normality test, normally distributed variables are presented in means and standard deviation, compared with Student;s t-test, those related with ANOVA test; quantitative variables of free distribution are presented in medians and interquartile ranges, compared with Mann Whitney U-test, those related with Kruskall-Wallis test. Data analysis was carried out with SPSS version 23, Graph Pad Prisma. A value p < 0.05 was taken as statistical significance, 95%.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric oxygen therapy | Other | Series of 30 HBOT sessions of 60 minutes at 2 ATA in the hyperbaric chamber for five consecutive days per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Gene expression of superoxide dismutase 1/ SOD1 | . Blood samples were collected and relative gene expression was assessed by quantitative real time polymerase chain reaction (qPCR). | The effect of the hyperbaric chamber was evaluated after sessions 12 and 30, each session lasting 60 minutes for five consecutive days per week, for a total of 6 weeks. |
| Gene expression of superoxide dismutase 2 | Blood samples were collected and relative gene expression was assessed by quantitative real time polymerase chain reaction (qPCR). | The effect of the hyperbaric chamber was evaluated after sessions 12 and 30, each session lasting 60 minutes for five consecutive days per week, for a total of 6 weeks. |
| Glutathione Peroxidase (GPX2) | Blood samples were collected and relative gene expression was assessed by quantitative real time polymerase chain reaction (qPCR). | The effect of the hyperbaric chamber was evaluated after sessions 12 and 30, each session lasting 60 minutes for five consecutive days per week, for a total of 6 weeks. |
| Interleukin-1β (IL-1β) | Blood samples were collected and relative gene expression was assessed by quantitative real time polymerase chain reaction (qPCR). | The effect of the hyperbaric chamber was evaluated after sessions 12 and 30, each session lasting 60 minutes for five consecutive days per week, for a total of 6 weeks. |
| Interleukin-4 (IL-4) | Blood samples were collected and relative gene expression was assessed by quantitative real time polymerase chain reaction (qPCR). | The effect of the hyperbaric chamber was evaluated after sessions 12 and 30, each session lasting 60 minutes for five consecutive days per week, for a total of 6 weeks. |
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Inclusion Criteria:
Men and women with diabetic foot and hyperbaric treatment. Ages 30-60 years. Signed informed consent form.
Exclusion Criteria:
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Women and men older than 18 years, with Diabetes type 2, residents of the CDMX, with diabetic foot with hyperbaric treatment, attended at the hospital of specialties in diabetes, secretary of health, accepted and signed the informed consent form
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Modesto Gómez López | Mexico City | Mexico City | 11340 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19949909 | Result | Godman CA, Chheda KP, Hightower LE, Perdrizet G, Shin DG, Giardina C. Hyperbaric oxygen induces a cytoprotective and angiogenic response in human microvascular endothelial cells. Cell Stress Chaperones. 2010 Jul;15(4):431-42. doi: 10.1007/s12192-009-0159-0. Epub 2009 Dec 1. | |
| 28545109 | Result | van Neck JW, Tuk B, Fijneman EMG, Redeker JJ, Talahatu EM, Tong M. Hyperbaric oxygen therapy for wound healing in diabetic rats: Varying efficacy after a clinically-based protocol. PLoS One. 2017 May 17;12(5):e0177766. doi: 10.1371/journal.pone.0177766. eCollection 2017. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 28, 2018 | Jun 20, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 28, 2018 | Jun 20, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| 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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| Interleukin-12 (IL-12) | Blood samples were collected and relative gene expression was assessed by quantitative real time polymerase chain reaction (qPCR). | The effect of the hyperbaric chamber was evaluated after sessions 12 and 30, each session lasting 60 minutes for five consecutive days per week, for a total of 6 weeks. |
| NLRP3 inflammasome (NOD-, LRR- and pyrin domain-containing protein 3) | Blood samples were collected and relative gene expression was assessed by quantitative real time polymerase chain reaction (qPCR). | The effect of the hyperbaric chamber was evaluated after sessions 12 and 30, each session lasting 60 minutes for five consecutive days per week, for a total of 6 weeks. |
| Tumor necrosis factor alpha (TNF-α) | Blood samples were collected and relative gene expression was assessed by quantitative real time polymerase chain reaction (qPCR). | The effect of the hyperbaric chamber was evaluated after sessions 12 and 30, each session lasting 60 minutes for five consecutive days per week, for a total of 6 weeks. |
| Result | undefined |
| 30831142 | Result | Dadmanesh M, Ranjbar MM, Ghorban K. Inflammasomes and their roles in the pathogenesis of viral hepatitis and their related complications: An updated systematic review. Immunol Lett. 2019 Apr;208:11-18. doi: 10.1016/j.imlet.2019.03.001. Epub 2019 Mar 1. |
| 20497028 | Result | Hsieh CP, Chiou YL, Lin CY. Hyperbaric oxygen-stimulated proliferation and growth of osteoblasts may be mediated through the FGF-2/MEK/ERK 1/2/NF-kappaB and PKC/JNK pathways. Connect Tissue Res. 2010 Dec;51(6):497-509. doi: 10.3109/03008201003746679. Epub 2010 May 24. |
| 28029181 | Result | Clokie M, Greenway AL, Harding K, Jones NJ, Vedhara K, Game F, Dhatariya KK. New horizons in the understanding of the causes and management of diabetic foot disease: report from the 2017 Diabetes UK Annual Professional Conference Symposium. Diabet Med. 2017 Mar;34(3):305-315. doi: 10.1111/dme.13313. Epub 2017 Jan 23. |
| 19298750 | Result | Matchett GA, Martin RD, Zhang JH. Hyperbaric oxygen therapy and cerebral ischemia: neuroprotective mechanisms. Neurol Res. 2009 Mar;31(2):114-21. doi: 10.1179/174313209X389857. |
| 20456243 | Result | Michalski D, Hartig W, Schneider D, Hobohm C. Use of normobaric and hyperbaric oxygen in acute focal cerebral ischemia - a preclinical and clinical review. Acta Neurol Scand. 2011 Feb;123(2):85-97. doi: 10.1111/j.1600-0404.2010.01363.x. |
| 17439697 | Result | Calvert JW, Cahill J, Zhang JH. Hyperbaric oxygen and cerebral physiology. Neurol Res. 2007 Mar;29(2):132-41. doi: 10.1179/016164107X174156. |
| 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 |