Hyperbaric Oxygen Therapy in Diabetic Foot

NCT06502808 | Completed DMC

• 1 other identifier: CEI-CICS-038
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Foot Ulcer Neuropathic

Keywords

Gene expression; Hyperbaric oxygen therapy; Diabetic foot

Outcome Measures

Primary Outcomes (8)

• 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.

• 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.

Interventions

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.

Eligibility Criteria

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

Study Population

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

You may qualify if:

• Men and women with diabetic foot and hyperbaric treatment. Ages 30-60 years. Signed informed consent form.

You may not qualify if:

• Patients with diabetic foot without presence of dermatologic lesions.

Sponsors & Collaborators

• National Polytechnic Institute, Mexico: lead

Study Sites (1)

Modesto Gómez López

Mexico City, Mexico City, 11340, Mexico

Location

Related Publications (9)

• 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.

  PMID: 19949909 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.

  PMID: 28545109 RESULT

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  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.

  PMID: 30831142 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.

  PMID: 20497028 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.

  PMID: 28029181 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.

  PMID: 19298750 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.

  PMID: 20456243 RESULT

• Calvert JW, Cahill J, Zhang JH. Hyperbaric oxygen and cerebral physiology. Neurol Res. 2007 Mar;29(2):132-41. doi: 10.1179/016164107X174156.

  PMID: 17439697 RESULT

MeSH Terms

Conditions

Diabetic Foot

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

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in Research in Medicine (Molecular Biology), School of Medicine, National Polytechnic Institute. Polytechnic Institute.

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 16, 2024
• Study Start: January 15, 2019
• Primary Completion: January 15, 2020
• Study Completion: July 15, 2020
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

ME (1)