Study Results
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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COMPLETED
15 participants
OBSERVATIONAL
2019-01-15
2020-07-15
Brief Summary
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Detailed Description
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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%.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Hyperbaric oxygen therapy
Series of 30 HBOT sessions of 60 minutes at 2 ATA in the hyperbaric chamber for five consecutive days per week.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Polytechnic Institute, Mexico
OTHER
Responsible Party
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Modesto Gómez López
Doctor in Research in Medicine (Molecular Biology), School of Medicine, National Polytechnic Institute. Polytechnic Institute.
Locations
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Modesto Gómez López
Mexico City, Mexico City, Mexico
Countries
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References
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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.
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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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.
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.
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.
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.
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.
Calvert JW, Cahill J, Zhang JH. Hyperbaric oxygen and cerebral physiology. Neurol Res. 2007 Mar;29(2):132-41. doi: 10.1179/016164107X174156.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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CEI-CICS-038
Identifier Type: -
Identifier Source: org_study_id
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