Effect of Photobiomodulation on Healing of Venous Leg Ulcers

Summary

This randomized, controlled, double-blind clinical trial will evaluate the efficacy of photobiomodulation (PBM) combined with compression therapy in the healing of venous ulcers (VUs) in the lower limbs. A total of 96 participants will be allocated into two groups: Experimental Group (PBM + compression) and Control Group (sham PBM + compression). Treatments will be administered twice weekly for 16 weeks (32 sessions). The primary outcome will be complete wound healing. Secondary outcomes include changes in ulcer area and volume, pain (VAS), quality of life (SF-36), clinical severity (VCSS), wound quality (Bates-Jensen Scale), infrared thermography, and treatment costs. Data will be analyzed using ANOVA or Kruskal-Wallis, chi-square or Fisher's exact test, and Kaplan-Meier survival analysis, with a significance level of p \< 0.05.

Conditions

• Venous Disease
• Venous Insufficiency (Chronic)(Peripheral)
• Venous Insufficiency of Leg
• Venous Leg Ulcer (VLU)
• Venous Leg Ulcer
• Venous Hypertension Ulcers
• Varicose Ulcers
• Varicose Ulcer of Lower Limb

Interventions

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.

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.

Sponsors & Collaborators

• University of Nove de Julho

  lead OTHER

Principal Investigators

• Anna C Ratto Tempestini Horliana, PhD · University of Nove de Julho

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2027-05-31

Completion

2027-07-31

Countries

• Brazil

Study Locations