Effect of Photobiomodulation on Healing of Venous Leg Ulcers

NCT07123285 | Not Yet Recruiting

• 1 other identifier: CAAE88980225
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Keywords

venous ulcers; varicose ulcers; photobiomodulation; lasers; phototherapy; venous leg ulcer

Outcome Measures

Primary Outcomes (1)

• Complete healing or reduction in venous ulcer size

  Defined as total re-epithelialization of the wound with no drainage and no need for dressings, or a significant reduction in wound size by the end of the treatment period.

  From enrollment to the end of the 16-week treatment period

Secondary Outcomes (7)

• Adverse events

  From the first treatment session to the end of the 16-week treatment period

• Wound quality assessment using the Bates-Jensen Wound Assessment Tool

  At baseline, week 4, week 8, and week 16

• Pain intensity measured by Visual Analog Scale

  Twice per week, over 16 weeks

• Quality of life assessment using SF-36 questionnaire

  At baseline and after 16 weeks

• Venous Clinical Severity Score (VCSS)

  At baseline, week 4, week 8, and week 16

Study Arms (2)

Photobiomodulation plus Compression Therapy

EXPERIMENTAL

Participants in this arm will receive photobiomodulation therapy using a low-level laser device with 4 emitters operating at 660 nm and 808 nm wavelengths. Each emitter delivers 6 Joules of energy at 100 mW power. Treatment sessions are conducted twice weekly (Monday and Wednesday) for 16 weeks, totaling 32 sessions. In addition, standard compression therapy will be applied as per clinical guidelines for venous leg ulcers.

Device: Photobiomodulation plus Compression Therapy

Compression Therapy plus Sham Photobiomodulation

SHAM COMPARATOR

Participants in this arm will receive sham photobiomodulation therapy using the same laser device but without active laser emission (placebo). Treatment sessions are also conducted twice weekly for 16 weeks, totaling 32 sessions. They will also receive standard compression therapy as per clinical guidelines for venous leg ulcers.

Device: Compression Therapy plus Sham Photobiomodulation

Interventions

Photobiomodulation plus Compression Therapy DEVICE

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.

Also known as: Low-Level Laser Therapy, Photobiomodulation, LLLT, Photobiomodulation Therapy with Low-Level Laser

Photobiomodulation plus Compression Therapy

Compression Therapy plus Sham Photobiomodulation DEVICE

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.

Also known as: Placebo Photobiomodulation, Laser Simulation, Placebo Laser Treatment, Inactive Laser Therapy

Compression Therapy plus Sham Photobiomodulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes;
• Individuals with venous ulcers in the lower limbs for at least three weeks that have not healed;
• Age between 18 and 85 years;
• Residents of Lençóis Paulista or nearby regions.

You may not qualify if:

• Patients with ulcers of non-venous etiology;
• Pregnant women;
• Presence of severe arterial disease in the lower limbs.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Estratégia da Saúde da Família Monte Azul - "Antonio Benedetti".

Lençóis Paulista, São Paulo, 18682768, Brazil

Location

MeSH Terms

Conditions

Venous Insufficiency; Varicose Ulcer

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Varicose Veins; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Anna C Ratto Tempestini Horliana, PhD

  University of Nove de Julho

  STUDY DIRECTOR

Central Study Contacts

Rayana G Moreira, MD

CONTACT

+5514981051703; rayanamoreira@hotmail.com

Anna C Ratto Tempestini Horliana, PhD

CONTACT

+5511948002288; annacrth@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this double-blind study, both the participants and the outcome assessors are blinded to the treatment assignments. However, the nurse administering the photobiomodulation therapy is not blinded and knows the group allocation in order to correctly perform the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a randomized, double-blind, controlled, parallel-group clinical trial with two arms: an Experimental Group receiving photobiomodulation therapy (PBM) plus compression therapy, and a Control Group receiving sham PBM plus compression therapy. Participants are allocated in a 1:1 ratio and will not cross over between groups. Each group receives 32 treatment sessions over a 16-week period.

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: When we have published the data

Locations

BR (1)