Effect of Photobiomodulation on the Healing of Lower-Limb Venous Ulcers: A Randomized, Double-Blind, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 3
- 主要终点
- Percentage Reduction in Wound Volume
研究概览
简要总结
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.
详细描述
Venous leg ulcers are chronic wounds associated with chronic venous disease, characterized by prolonged healing, frequent recurrence, pain, functional limitations, reduced quality of life, and substantial treatment costs. Compression therapy is the standard treatment for venous leg ulcers. Photobiomodulation may enhance tissue repair and is being investigated as an adjunct to standard wound care and compression therapy.
This is a prospective, randomized, controlled, double-blind, parallel-group clinical trial. A total of 102 participants with lower-limb venous ulcers will be randomly allocated in a 1:1 ratio to two groups. The Experimental Group (n=51) will receive active photobiomodulation combined with standard wound care and compression therapy. The Control Group (n=51) will receive sham photobiomodulation combined with the same standard wound care and compression therapy.
All ulcers will be cleansed with 0.9% saline solution at room temperature using the study site's standardized wound-care procedure. Devitalized tissue will be debrided when indicated. Hydrogel and alginate will be used as standard primary dressings, followed by sterile gauze, bandage, and adhesive tape as the secondary dressing. Participants will receive supplies and instructions to replace the primary and secondary dressings at home once daily. Compression therapy will consist of 30-mmHg compression stockings worn daily on the affected limb, removed only for bathing and sleeping. Participants will be instructed to maintain their usual nutritional intake, alternate isometric exercises with rest periods, elevate the lower limbs, and adopt healthy lifestyle habits.
Active photobiomodulation will be delivered with the e-Light IRL cluster device (DMC Equipamentos, Brazil; ANVISA registration No. 80030810174). The cluster contains eight emitters: four red emitters at 660 nm and four infrared emitters at 808 nm. Each emitter has an output power of 100 mW and delivers 6 J during a 60-second application, resulting in a total device output power of 800 mW. The applicator will be positioned perpendicular to the wound bed and applied by direct contact through a disposable transparent PVC film. The participant and treatment team will use appropriate protective eyewear.
Sham photobiomodulation will use the same device positioning and application duration, but the device will remain switched off without therapeutic light emission. Participants will wear an eye covering, and a recorded sound similar to the operating device will be reproduced to maintain participant blinding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants and the examiner responsible for pre- and post-procedure assessments will be blinded to allocation. The nurse administering active or sham photobiomodulation will be the only team member aware of the assigned intervention. The sham procedure will reproduce device positioning and application time; the device will remain switched off, participants will wear an eye covering, and a recorded operating sound will be played.
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants of either sex.
- •Age 19 to 85 years.
- •Lower-limb venous ulcer present for at least 6 weeks and not healed.
- •Ulcer without infection at enrollment.
- •Operational confirmation before enrollment:
- •Venous etiology confirmed by Doppler ultrasonography demonstrating venous reflux.
- •Ankle-Brachial Index ≥0.8 to exclude concomitant arterial disease.
- •Written informed consent.
排除标准
- •Ulcer of non-venous etiology.
- •Pregnancy.
- •Severe lower-limb arterial disease.
- •Current use or initiation of another venous-ulcer treatment different from the study treatment.
- •Protocol Discontinuation Criteria
- •Wound worsening with onset of infection.
- •Any complication during the procedure requiring discontinuation for participant safety.
研究组 & 干预措施
Photobiomodulation
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.
干预措施: Compression Therapy (Procedure)
Photobiomodulation
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.
干预措施: Photobiomodulation Therapy (Device)
Sham Photobiomodulation
The same device positioning and application duration will be used, but the device will remain switched off and will not emit therapeutic light. Participants will wear an eye covering, and a recorded sound similar to the operating device will be reproduced to maintain blinding.
干预措施: Sham Photobiomodulation (Device)
Sham Photobiomodulation
The same device positioning and application duration will be used, but the device will remain switched off and will not emit therapeutic light. Participants will wear an eye covering, and a recorded sound similar to the operating device will be reproduced to maintain blinding.
干预措施: Compression Therapy (Procedure)
结局指标
主要结局
Percentage Reduction in Wound Volume
时间窗: Baseline, Month 1, Month 2, and Month 4
Percentage reduction in wound volume over 16 weeks. Volume will be calculated as wound area (cm²) multiplied by wound depth (cm). Area will be estimated using the modified ellipse formula: length × width × 0.785. Depth will be measured at the deepest point with a sterile graduated probe. Percentage reduction will be calculated as \[(baseline volume - follow-up volume) / baseline volume\] × 100. For wounds with depth ≤0.1 cm, depth will be classified as zero for volumetric analysis, and healing response will be evaluated using percentage reduction in wound area.
Complete healing or reduction in venous ulcer size
时间窗: From enrollment to the end of the 16-week treatment period
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.
次要结局
- Wound area measurement using ImitoWound®(At baseline, week 4, week 8, and week 16)
- Adverse events(From the first treatment session through Week 16)
- Bates-Jensen Wound Assessment Tool Score(Baseline, Month 1, Month 2, and Month 4)
- Pain intensity(Before and after each treatment session, twice weekly for 16 weeks)
- Health-Related Quality of Life(Baseline and Month 4)
- Venous Clinical Severity Score (VCSS)(Baseline, Month 1, Month 2, and Month 4)
- Direct Treatment Cost(Cumulative from treatment initiation through Week 16)
- Complete healing(From enrollment to the end of the treatment period - Month 4)
- 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)
- Wound area measurement using ImitoWound®(At baseline, week 4, week 8, and week 16)
- Thermography (lesion and periwound temperature)(Before and after each treatment session, twice weekly for 16 weeks)
- Total treatment cost(Cumulative from the start of treatment to the end of the 16-week treatment period)
研究者
Anna Carolina Ratto Tempestini Horliana
Professor
University of Nove de Julho