Hyperbaric Oxygen Therapy in Diabetic Foot (HBOTDF)

July 9, 2024 updated by: Modesto Gómez López, National Polytechnic Institute, Mexico

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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%.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Cdmx
      • Mexico City, Cdmx, Mexico, 11340
        • Modesto Gómez López

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with diabetic foot without presence of dermatologic lesions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
. 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
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Polytechnic Institute, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CEI-CICS-038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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