Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353568
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-02-27
Brief Title:
Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot
Sponsor:
University of Nove de Julho
Organization:
University of Nove de Julho
Study Overview
Official Title:
Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot Randomized Controlled Blinded Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study seeks to evaluate the effect of photobiomodulation PBM in the prevention of Diabetic foot DF in patients at moderate and high risk for its development through a controlled randomized double-blind clinical trial Individuals between 18 and 75 years old of both sexes with type 2 diabetes mellitus DM and moderate and high risk for DF will be randomized and allocated into 2 groups of 32 participants each The PBM Group will use a boot with 1344 LEDs 504 of which are 660 nm located on the sides of the boot 285 milliwatt 10 J per LED 504 850 nm also located on the sides of the boot 23 milliwatt 8 J per LED 168 of 660 nm located at the base of the boot 285 milliwatt 10 J per LED 168 of 850 nm also located at the base of the boot 23 milliwatt 8 J per LED once a day for 6 minutes for 60 days and will receive therapeutic education Participants will be evaluated at baseline after 30 days clinical examination and after 60 days clinical examination Peripheral Neuropathy PN assessment Peripheral Artery Disease PAD assessment blood and urine tests and quality of life
Detailed Description:
Diabetic foot DF prevention involves risk classification systemic care assessment of Peripheral Artery Disease PAD and Peripheral Neuropathy PN regular foot examination therapeutic education and routine use of appropriate footwear Photobiomodulation PBM has been successfully applied in the healing of DF In addition to the therapeutic effects of PBM its preventive effects have attracted the attention of researchers This study seeks to evaluate the effect of PBM in the prevention of DF in patients at moderate and high risk for its development through a controlled randomized double-blind clinical trial Individuals between 18 and 75 years old of both sexes with type 2 DM and moderate and high risk for DF will be randomized and allocated into 2 groups of 32 participants each The PBM Group will use a boot with 1344 LEDs 504 of which are 660 nm located on the sides of the boot 285 milliwatt 10 J per LED 504 850 nm also located on the sides of the boot 23 milliwatt 8 J per LED 168 of 660 nm located at the base of the boot 285 milliwatt 10 J per LED 168 of 850 nm also located at the base of the boot 23 milliwatt 8 J per LED once a day for 6 minutes for 60 days and will receive therapeutic education Participants will be evaluated at baseline and after 30 days clinical examination and 60 days clinical examination PN assessment PAD assessment blood and urine tests and quality of life The collected data will be stored and organized in a repository and the appropriate statistical tests will be applied for each specific analysis In all tests a significance level of 5 will be adopted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None