Comparison Between Isolated Foam Sclerotherapy and Foam Sclerotherapy Combined With Transdermal Laser for the Treatment of Reticular Veins and Telangiectasias: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Percent Change in Residual Vascular Area From Baseline to Days 60, 90 and 180
研究概览
简要总结
his prospective, randomized, controlled, intraindividual split-leg clinical trial will compare isolated polidocanol foam sclerotherapy with the Laser After Foam (LAAF) technique for the treatment of reticular veins and telangiectasias of the lower limbs. The study will include 70 women aged 18 to 60 years with bilateral CEAP C1 telangiectasias and/or reticular veins. Each participant will receive LAAF in one lower limb and isolated foam sclerotherapy in the contralateral limb, with treatment laterality determined by randomization. The study will evaluate vascular clearance, residual vascular area, hyperpigmentation, retained thrombi and need for drainage, pain, adverse events, aesthetic improvement, patient satisfaction, and quality of life during follow-up through 180 days.
详细描述
Telangiectasias and reticular veins are common manifestations of chronic venous disease classified as CEAP C1. Although they are frequently considered primarily aesthetic findings, they may be associated with local symptoms and may negatively affect quality of life and body perception.
Foam sclerotherapy with polidocanol is widely used for the treatment of reticular veins and telangiectasias. However, post-treatment hyperpigmentation, retained thrombi, telangiectatic matting, superficial phlebitis, prolonged ecchymosis, and the need for drainage may occur.
The Laser After Foam (LAAF) technique combines chemical sclerotherapy with subsequent transdermal laser treatment. In this technique, polidocanol foam is injected first, followed immediately by application of a long-pulsed 1064 nm Nd:YAG laser over the foam-filled treated vessels. The proposed rationale is that combining chemical and photothermal mechanisms may enhance vascular occlusion and potentially reduce residual intravascular blood, retained thrombi, and hyperpigmentation.
This is a prospective, randomized, controlled, intraindividual, split-leg, assessor-blinded, single-center clinical trial. Seventy participants with bilateral relatively symmetrical CEAP C1 telangiectasias and/or reticular veins will be included. Randomization will determine which lower limb receives LAAF, while the contralateral limb receives isolated foam sclerotherapy. Each participant will therefore serve as her own control.
Treatment will be performed in standardized bilateral 20 × 15 cm areas of the lateral thigh-leg region. Standardized digital photographs and semiautomated image analysis will be used to assess residual vascular area and vascular clearance. Skin pigmentation will also be evaluated clinically, photographically, and instrumentally with a Mexameter®. Additional outcomes will include Global Aesthetic Improvement Scale (GAIS), pain, retained thrombi, need for drainage, matting, superficial phlebitis, other adverse events, patient satisfaction, and quality of life. Follow-up assessments are planned through 180 days.
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
- Single (Outcomes Assessor)
盲法说明
The operator cannot be blinded due to the nature of the interventions. Participants will receive standardized instructions not to disclose to the outcome assessors which lower limb received laser treatment. Outcome assessors will be blinded to treatment allocation and laterality. Standardized photographs will be coded and presented without identification of the treated limb, treatment date, or intervention. Two independent assessors will evaluate the images separately. In case of clinically relevant disagreement, a third blinded assessor will perform adjudication.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 18 to 60 years.
- •Fitzpatrick skin phototype I, II, or III.
- •CEAP clinical class C
- •Bilateral relatively symmetrical presence of telangiectasias and reticular veins on the lateral thigh.
- •Presence of telangiectasias and reticular veins measuring 0.1 to 3 mm in diameter.
- •Body mass index (BMI) ≤ 30 kg/m²
- •Willingness to participate in the complete study follow-up and provision of written informed consent.
排除标准
- •Saphenous or perforator venous reflux.
- •Varicose veins greater than 3 mm in diameter (CEAP C2-C6).
- •Fitzpatrick skin phototype IV, V, or VI.
- •Recent venous thrombosis or known thrombophilia.
- •Use of anticoagulant therapy.
- •Pregnancy or breastfeeding.
- •Known allergy to polidocanol.
- •Peripheral arterial disease with ankle-brachial index (ABI) < 0.
- •Diabetes mellitus.
- •Local dermatitis in the treatment area.
- •Previous venous treatment within the last 6 months.
- •Failure to attend the treatment session or scheduled follow-up visits.
研究组 & 干预措施
Isolated Foam Sclerotherapy
The lower limb allocated to the control treatment will receive isolated sclerotherapy with 0.5% polidocanol foam within the standardized treatment area. The contralateral lower limb of the same participant will receive Laser After Foam (LAAF). Treatment laterality will be determined by randomization
干预措施: Polidocanol foam sclerotherapy (Drug)
Laser After Foam (LAAF)
The lower limb allocated to LAAF will receive 0.5% polidocanol foam sclerotherapy followed immediately by long-pulsed transdermal 1064 nm Nd:YAG laser treatment over the treated foam-filled vessels. The contralateral lower limb of the same participant will receive isolated foam sclerotherapy
干预措施: Transdermal 1064 nm Nd:YAG Laser (Device)
Laser After Foam (LAAF)
The lower limb allocated to LAAF will receive 0.5% polidocanol foam sclerotherapy followed immediately by long-pulsed transdermal 1064 nm Nd:YAG laser treatment over the treated foam-filled vessels. The contralateral lower limb of the same participant will receive isolated foam sclerotherapy
干预措施: Polidocanol foam sclerotherapy (Drug)
结局指标
主要结局
Percent Change in Residual Vascular Area From Baseline to Days 60, 90 and 180
时间窗: Baseline and Day 60,90 and 180
Residual vascular area will be quantified from standardized digital photographs using semiautomated image analysis, preferably with ImageJ/Fiji, within the standardized 20 × 15 cm treatment area. Change in residual vascular area will be expressed as a percentage relative to baseline at each follow-up time point. The paired intraindividual comparison will be performed between the area treated with Laser After Foam (LAAF) and the contralateral area treated with isolated foam sclerotherapy.
次要结局
- Vascular Clearance by Blinded Photographic Assessment(Day 60, Day 90, and Day 180)
- Global Aesthetic Improvement Scale (GAIS) Score(Day 60, Day 90, and Day 180)
- Incidence and Intensity of Hyperpigmentation(Day 60, Day 90, and Day 180)
- Change in Melanin Index Measured With Mexameter(Baseline, Day 60, Day 90, and Day 180)
- Incidence of Retained Thrombus and Need for Drainage(Day 21)
- Procedure-Related Pain(Day 0)
- Incidence of Telangiectatic Matting, Superficial Phlebitis, Persistent Ecchymosis, Skin Necrosis or Wound, Thromboembolic Events(Day 60, Day 90 and Day 180)
- Change in Chronic Venous Insufficiency Questionnaire-14 (CIVIQ-14) Global Index Score From Baseline to Days 90 and 180(Baseline, Day 90, and Day 180)
- Change in VEINES-QOL Score From Baseline to Days 90 and 180(Baseline, Day 90, and Day 180)
- Change in VEINES-Sym Score From Baseline to Days 90 and 180(Baseline, Day 90, and Day 180)
研究者
Cecília Salazar Ulacia
Principal Investigator
University of Sao Paulo