104
Participants
Start Date
September 1, 2025
Primary Completion Date
October 1, 2026
Study Completion Date
February 1, 2027
Photobiomodulation plus Compression Therapy
This intervention uses a low-level laser device with 8 emitters, including 4 red emitters at 660 nm and 4 infrared emitters at 808 nm. Each emitter delivers 6 Joules of energy at 100 mW power, with a total power output of 800 mW. Treatment is administered twice weekly over 16 weeks, totaling 32 sessions per participant. The device is used in combination with standard compression therapy for venous leg ulcer management.
Compression Therapy plus Sham Photobiomodulation
This intervention uses a sham photobiomodulation therapy with the same laser device used in the active group but without emission of therapeutic laser light (inactive device). The device appears identical and the treatment sessions are conducted twice weekly over 16 weeks, totaling 32 sessions per participant. Participants also receive standard compression therapy for venous leg ulcer management. This sham procedure is designed to mimic the active treatment without delivering any laser energy, serving as a placebo control.
"Estratégia da Saúde da Família Monte Azul - Antonio Benedetti.", Lençóis Paulista
University of Nove de Julho
OTHER