Effect of Photobiomodulation on Healing of Venous Leg Ulcers

NANot yet recruitingINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

October 1, 2026

Study Completion Date

February 1, 2027

Conditions
Venous DiseaseVenous Insufficiency (Chronic)(Peripheral)Venous Insufficiency of LegVenous Leg Ulcer (VLU)Venous Leg UlcerVenous Hypertension UlcersVaricose UlcersVaricose Ulcer of Lower Limb
Interventions
DEVICE

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.

DEVICE

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.

Trial Locations (1)

18682768

"Estratégia da Saúde da Família Monte Azul - Antonio Benedetti.", Lençóis Paulista

All Listed Sponsors
lead

University of Nove de Julho

OTHER

NCT07123285 - Effect of Photobiomodulation on Healing of Venous Leg Ulcers | Biotech Hunter | Biotech Hunter