Actively Recruiting
Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot
Led by University of Nove de Julho · Updated on 2024-10-08
64
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 (28.5 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 (28.5 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).
CONDITIONS
Official Title
Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals diagnosed with type 2 Diabetes Mellitus (according to American Diabetes Association 2021 criteria)
- Both sexes
- Between 18 and 75 years old
- Classified as moderate to high risk for developing diabetic foot according to the International Working Group on the Diabetic Foot (IWGDF-2019) scale
You will not qualify if you...
- Pregnant women
- Individuals diagnosed with type 1 diabetes
- Individuals with neuropathy due to uncontrolled conditions like hypothyroidism, vitamin B12 deficiency, or alcoholism
- Individuals with active infection at the time of inclusion
- Individuals with active ulcers or infectious skin lesions on legs or feet
- Individuals with a history of osteomyelitis
- Individuals with Parkinson's disease
- Individuals with contracture conditions
- Individuals with severe lower limb ischemia (Fontaine III and IV - Rutherford 4 to 6)
- Individuals with suspicious skin lesions for cancer or dysplasias on legs or feet
- Individuals diagnosed with cancer or undergoing cancer treatment within the last 3 months
- Individuals with unstable angina, recent heart attack, or severe arrhythmia within the last 6 months
- Individuals with decompensated Chronic Obstructive Pulmonary Disease (COPD)
- Individuals unable to understand the informed consent form
- Individuals unable to attend appointments regularly
AI-Screening
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Trial Site Locations
Total: 1 location
1
Conjunto Hospitalar do Mandaqui
São Paulo, São Paulo, Brazil, 02401-400
Actively Recruiting
Research Team
K
Kristianne KS Fernandes, PhD
CONTACT
R
Roselene Lourenço, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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