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AzTrials

Diabetic Foot Ulcer NeuropathicHBOTDFNCT06502808

Hyperbaric Oxygen Therapy in Diabetic Foot

An observational study of Diabetic Foot Ulcer Neuropathic, run by National Polytechnic Institute, Mexico at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Foot Ulcer Neuropathic
What is being tested?
Hyperbaric oxygen therapy
How many people
15 participants
Where
1 siteMexico
Study dates
15 Jan 2019to 15 Jul 2020
How long will I take part?
15 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Patients with diabetic foot without presence of dermatologic lesions.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Modesto Gómez López

    Mexico City, Mexico City, 11340

Other trials in Mexico

About this study

Official title: The Effect of Hyperbaric Oxygen Therapy on Oxidative Stress and Inflammation in Patients With Diabetic Foot Ulcers

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

Read the detailed description

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%.

Being tested
Hyperbaric oxygen therapy
Keywords
Gene expression, Hyperbaric oxygen therapy, Diabetic foot
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyperbaric oxygen therapyOther

    Series of 30 HBOT sessions of 60 minutes at 2 ATA in the hyperbaric chamber for five consecutive days per week.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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.

  2. Gene expression of superoxide dismutase 2

    Blood samples were collected and relative gene expression was assessed by quantitative real time polymerase chain reaction (qPCR).

    Measured: 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.

  3. Glutathione Peroxidase (GPX2)

    Blood samples were collected and relative gene expression was assessed by quantitative real time polymerase chain reaction (qPCR).

    Measured: 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.

  4. Interleukin-1β (IL-1β)

    Blood samples were collected and relative gene expression was assessed by quantitative real time polymerase chain reaction (qPCR).

    Measured: 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.

  5. Interleukin-4 (IL-4)

    Blood samples were collected and relative gene expression was assessed by quantitative real time polymerase chain reaction (qPCR).

    Measured: 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.

  6. Interleukin-12 (IL-12)

    Blood samples were collected and relative gene expression was assessed by quantitative real time polymerase chain reaction (qPCR).

    Measured: 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.

  7. 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).

    Measured: 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.

  8. Tumor necrosis factor alpha (TNF-α)

    Blood samples were collected and relative gene expression was assessed by quantitative real time polymerase chain reaction (qPCR).

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2024
  2. Study start15 Jan 2019
  3. Primary completion15 Jan 2020
  4. Study completion15 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
15 participants (actual)
Target duration
15 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06502808
Sponsor's protocol ID
CEI-CICS-038
Acronym
HBOTDF
Status last verified
Jul 2024
First submitted
20 Jun 2024
Last updated
16 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 19949909

  • 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.

    PubMed 28545109

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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.

    PubMed 30831142

  • 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.

    PubMed 20497028

  • 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.

    PubMed 28029181

  • 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.

    PubMed 19298750

  • 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.

    PubMed 20456243

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

    PubMed 17439697

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Foot Ulcer Neuropathic, run by National Polytechnic Institute, Mexico at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gene expression of superoxide dismutase 1/ SOD1 (time frame: 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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06502808, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.

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