Effect of Photobiomodulation on Healing of Venous Leg Ulcers

Summary

Venous leg ulcers are a significant public health problem because of their prolonged duration, high recurrence rates, and economic, social, and quality-of-life effects. Compression therapy is the standard treatment; however, healing may remain slow. Photobiomodulation is being investigated as an adjunctive treatment to promote tissue repair and wound healing.

This prospective, randomized, controlled, double-blind clinical trial will evaluate the efficacy of photobiomodulation combined with compression therapy in the healing of lower-limb venous leg ulcers. A total of 102 participants will be randomly allocated in a 1:1 ratio to an Experimental Group (n=51), receiving active photobiomodulation plus compression therapy, or a Control Group (n=51), receiving sham photobiomodulation plus compression therapy. Treatment will be administered twice weekly on Mondays and Thursdays for 16 weeks, totaling 32 sessions.

The primary outcome will be the percentage reduction in wound volume over 16 weeks, estimated from wound area and depth. Secondary outcomes will include percentage reduction in wound area, change in wound depth, complete wound healing, adverse events, wound quality assessed using the Bates-Jensen Wound Assessment Tool, pain intensity and rescue analgesic use, health-related quality of life assessed using the SF-36, clinical severity assessed using the Venous Clinical Severity Score, and direct treatment costs. Wound area will be measured using the ImitoWound® application.

Conditions

• Venous Leg Ulcer (VLU)
• Venous Hypertension Ulcers
• Chronic Venous Insufficiency
• Chronic Venous Disease

Interventions

DEVICE

Photobiomodulation Therapy

The e-Light IRL cluster device (DMC Equipamentos, Brazil; ANVISA No. 80030810174) contains eight emitters: four at 660 nm and four at 808 nm. Each emitter has an output power of 100 mW and delivers 6 J over 60 seconds. Total output power is 800 mW. The applicator will be positioned perpendicular to the wound bed and applied by direct contact through disposable transparent PVC film. Appropriate protective eyewear will be used. Participants will receive active photobiomodulation twice weekly on Mondays and Thursdays for 16 weeks, totaling 32 sessions.

DEVICE

Sham Photobiomodulation

This intervention uses sham photobiomodulation therapy with the same laser device as in the active group, but without emitting 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 the management of venous leg ulcers. This sham procedure is designed to mimic the active treatment without delivering any laser energy, serving as a placebo control.

PROCEDURE

Compression Therapy

All study participants received standardized wound care and compression therapy using 30-mmHg compression stockings.

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

19 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-31

Primary Completion

2027-05-31

Completion

2027-07-31

Countries

• Brazil

Study Locations