Hyperbaric Oxygen Therapy in Diabetic Foot

Completed

• Conditions: Diabetic Foot Ulcer Neuropathic

• Registration Number: NCT06502808
• Lead Sponsor: National Polytechnic Institute, Mexico

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

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 Timeline

• Study Start: 2019-01-15
• Primary Completion: 2020-01-15
• Study Completion: 2020-07-15
• Study First Submitted: 2024-06-20
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-09
• Last Update Submitted: 2024-07-09
• Study First Posted: 2024-07-16
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gene expression of superoxide dismutase 2	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).
Glutathione Peroxidase (GPX2)	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).
Interleukin-4 (IL-4)	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).
Gene expression of superoxide dismutase 1/ SOD1	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).
Interleukin-1β (IL-1β)	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).
Interleukin-12 (IL-12)	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).
Tumor necrosis factor alpha (TNF-α)	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).
NLRP3 inflammasome (NOD-, LRR- and pyrin domain-containing protein 3)	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).

Trial Locations

Locations (1)

Modesto Gómez López; 🇲🇽 Mexico City, Cdmx, Mexico