Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06502808
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-20
Brief Title:
Hyperbaric Oxygen Therapy in Diabetic Foot
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Hyperbaric Oxygen Therapy on Oxidative Stress and Inflammation in Patients With Diabetic Foot Ulcers
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HBOTDF
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 Students 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 005 was taken as statistical significance 95
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 Students 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 005 was taken as statistical significance 95
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None