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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

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

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

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)

January 15, 2019

Primary Completion (Actual)

January 15, 2020

Study Completion (Actual)

July 15, 2020

Study Registration Dates

First Submitted

June 20, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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