Using LED light to prevent diabetic foot complications
Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot: Randomized Controlled Blinded Clinical Study
This study is testing if a special LED light treatment can help prevent foot problems in people with type 2 diabetes who are at risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Nove de Julho Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT06353568 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of photobiomodulation (PBM) in preventing diabetic foot complications in patients with type 2 diabetes at moderate to high risk. Participants aged 18 to 75 will be randomly assigned to either a PBM group, which uses a specialized boot with 1344 LEDs for daily treatment, or a control group. The study will assess participants' health through clinical examinations and various tests at baseline, 30 days, and 60 days. The goal is to determine if PBM can reduce the incidence of diabetic foot issues through a controlled, double-blind methodology.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 75 with type 2 diabetes classified as moderate to high risk for developing diabetic foot.
Not a fit: Patients with type 1 diabetes or those with severe lower limb ischemia or active infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of diabetic foot complications in at-risk patients.
How similar studies have performed: Previous studies have shown promising results for photobiomodulation in healing diabetic foot ulcers, suggesting potential for preventive applications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals diagnosed with type 2 Diabetes Mellitus (according to American Diabetes Association 2021 criteria), * both sexes, * between 18 and 75 years, * Individuals classified, according to the International Working Group on the Diabetic Foot (IWGDF- 2019) scale, as moderate to high risk for developing diabetic foot, Exclusion Criteria: * Pregnant women * Individuals diagnosed with type 1 diabetics, * Individuals with neuropathy secondary to uncontrolled conditions (hypothyroidism, vitamin B12 deficiency, alcoholism), * Individuals diagnosed with active infectious condition at the time of inclusion, * Individuals diagnosed with active ulcer or infectious skin lesion on the legs/feet, * Individuals with historic of osteomyelitis, * Individuals with Parkinson's disease, * Individuals with contracture condition, * Individuals with severe lower limb ischemia (Fontaine III and IV - Rutherford 4 to 6), * Individuals with a suspicious skin lesion for neoplasms or cutaneous dysplasias on the legs/feet * Individuals diagnosed with oncologic disease or undergoing treatment within the last 3 (three) months, * Individuals presenting unstable angina, recent acute myocardial infarction, history of severe arrhythmia within the last six months, * Individuals diagnosed with decompensated Chronic Obstructive Pulmonary Disease (COPD), * Inability to understand the ICF, * Inability to attend appointments regularly.
Where this trial is running
São Paulo, São Paulo
- Conjunto Hospitalar do Mandaqui — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Kristianne KS Fernandes, PhD — University of Nove de Julho
- Study coordinator: Kristianne KS Fernandes, PhD
- Email: kristianneporta@gmail.com
- Phone: +55 011 33859287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.