Effect of Photobiomodulation on Healing of Venous Leg Ulcers

Sponsor
University of Nove de Julho
Study ID
NCT07123285
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Aug 14, 2025
Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Photobiomodulation plus Compression Therapy
    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.
  • Sham Comparator: Compression Therapy plus Sham Photobiomodulation
    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.

Primary Outcome Measure

Complete healing or reduction in venous ulcer size [ Time Frame: From enrollment to the end of the 16-week treatment period ]

Central Contacts

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