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Completed

NCT Number: NCT06502808

Hyperbaric Oxygen Therapy in Diabetic Foot

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

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Key information

Conditions

Diabetic Foot Ulcer Neuropathic Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Modesto Gómez López

Mexico City, 11340, Mexico

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

Sponsors and collaborators

Lead sponsor

National Polytechnic Institute, Mexico

Other

Registry information

Official study title

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

Acronym: HBOTDF

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 16, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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