Chronic Venous Disease, Reticular Veins, Telangiectasias
Conditions
Keywords
CEAP C1, Foam Sclerotherapy, Polidocanol, Laser After Foam, Nd:YAG Laser, LAAF, Hyperpigmentation
Brief summary
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.
Detailed description
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.
Interventions
Polidocanol 0.5% foam will be prepared immediately before application using the Tessari technique by mixing 1 mL of 0.5% polidocanol with 4 mL of room air in a 1:4 ratio, using two syringes connected by a three-way stopcock and 20 passages for homogenization. A maximum volume of 2 mL will be used per treated area. Intravascular microinjections will be performed with a fine needle, preferably 27.5G, in fractionated volumes and at a controlled rate. After treatment, standardized light local compression will be maintained for 24 hours.
DEVICETransdermal 1064 nm Nd:YAG Laser
Immediately after polidocanol foam sclerotherapy, a long-pulsed transdermal 1064 nm Nd:YAG laser will be applied over the treated foam-filled vessels. Continuous cold-air cooling at approximately -20°C will be used during laser application. Approximately 10% spot overlap, up to two passes over the target vein, and a maximum of 50 shots per treated area will be used unless interruption is required for safety. For telangiectasias smaller than 1 mm, the parameters will be a 2 mm spot, 200 J/cm² fluence, and 10-20 ms pulse duration. For reticular veins measuring 1-3 mm, the parameters will be a 6 mm spot, 70 J/cm² fluence, and 30-60 ms pulse duration.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Intraindividual split-leg design. Each participant receives both study interventions in standardized contralateral lower-limb treatment areas. Randomization in a 1:1 ratio determines which lower limb receives Laser After Foam (LAAF); the contralateral lower limb receives isolated polidocanol foam sclerotherapy. Each participant therefore serves as her own control
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Female participants aged 18 to 60 years. * Fitzpatrick skin phototype I, II, or III. * CEAP clinical class C1. * 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.
Exclusion criteria
* 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) \< 0.8. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Residual Vascular Area From Baseline to Days 60, 90 and 180 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vascular Clearance by Blinded Photographic Assessment | Day 60, Day 90, and Day 180 | Standardized digital photographs will be independently assessed by two blinded outcome assessors. Vascular clearance will be evaluated by comparing follow-up images with baseline images within the standardized treatment area. In case of clinically relevant disagreement, a third blinded assessor will perform adjudication. |
| Global Aesthetic Improvement Scale (GAIS) Score | Day 60, Day 90, and Day 180 | Global aesthetic improvement will be assessed using the protocol-adapted Global Aesthetic Improvement Scale (GAIS), ranging from -1 to 3. A score of -1 indicates worsening, 0 indicates no change, 1 indicates improvement, 2 indicates marked improvement, and 3 indicates very marked improvement or excellent aesthetic result |
| Incidence and Intensity of Hyperpigmentation | Day 60, Day 90, and Day 180 | Post-treatment hyperpigmentation will be assessed clinically and photographically in the treated area. Hyperpigmentation will be recorded as present or absent and its clinical intensity will be documented. Results will be compared between the LAAF-treated limb and the contralateral limb treated with isolated foam sclerotherapy. |
| Change in Melanin Index Measured With Mexameter | Baseline, Day 60, Day 90, and Day 180 | Skin pigmentation will be objectively measured using the Mexameter. Standardized measurement points will include the area of greatest pigmentation, when present, and adjacent untreated control skin. Each point will be measured three consecutive times and the arithmetic mean will be used. Change in melanin index will be compared with baseline and adjacent untreated skin. |
| Incidence of Retained Thrombus and Need for Drainage | Day 21 | Retained thrombus will be assessed clinically and defined as palpable or visible thrombotic material within the treated venous segment. The presence or absence, approximate size, associated pain, and need for drainage will be recorded. The need for drainage of retained thrombus will be recorded. Drainage may be indicated in the presence of a dark superficial thrombus, painful palpable cord, intravascular nodule, or local pain equal to or greater than 4 on the pain scale, according to the clinical assessor. When performed, the treated limb, date, approximate drained volume, and complications will be recorded. |
| Procedure-Related Pain | Day 0 | Pain will be assessed using a numerical rating scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain will be recorded for the sclerotherapy stage, the transdermal laser stage when applicable, and the overall procedure |
| Incidence of Telangiectatic Matting, Superficial Phlebitis, Persistent Ecchymosis, Skin Necrosis or Wound, Thromboembolic Events | Day 60, Day 90 and Day 180 | Telangiectatic matting will be defined as the appearance of new fine network-like telangiectasias within the treated area. Presence or absence and extension of matting will be recorded and compared between treatment techniques. Superficial phlebitis will be assessed clinically based on pain, erythema, and induration along the treated venous segment. Severity and any treatment instituted will be recorded. Persistent ecchymosis will be assessed clinically and defined as ecchymosis persisting beyond the expected post-treatment period or considered clinically relevant during follow-up. Its extent and resolution will be documented. Skin necrosis or wound will be defined as loss of skin integrity within the treated area. When present, lesion dimensions, treatment instituted, and clinical evolution will be recorded. Suspected thromboembolic events, including deep vein thrombosis or pulmonary embolism, will be investigated and recorded. Diagnostic confirmation, clinical management, and notifi |
| 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 | Quality of life related to chronic venous disease will be assessed using the Chronic Venous Insufficiency Questionnaire-14 (CIVIQ-14). The questionnaire contains 14 items. Scores will be calculated according to the prespecified scoring method and expressed on a 0 to 100 Global Index Score, with higher scores indicating better quality of life. Change from baseline will be assessed at Day 90 and Day 180. This is a participant-level outcome and will not be attributed separately to either lower limb or intervention. |
| Change in VEINES-QOL Score From Baseline to Days 90 and 180 | Baseline, Day 90, and Day 180 | Venous disease-specific quality of life will be assessed using the Brazilian Portuguese version of the Venous Insufficiency Epidemiological and Economic Study Quality of Life/Symptoms questionnaire (VEINES-QOL/Sym). The VEINES-QOL score is derived from 25 items included in questions 1, 3, 4, 5, 6, 7, and 8; question 2 is descriptive and is not included in the score. The score will be calculated using intrinsic scoring. After orienting item responses so that higher values indicate a better health status, each item response will be transformed using (i-1)/(k-1), where i is the response category and k is the number of response categories for that item. The mean of the available transformed items will then be multiplied by 100. The VEINES-QOL score ranges from 0 to 100, with higher scores indicating better venous disease-specific quality of life. The score will not be calculated when more than 50% of the relevant items are missing. Change from baseline will be assessed at Day 90 and Day |
| Change in VEINES-Sym Score From Baseline to Days 90 and 180 | Baseline, Day 90, and Day 180 | Venous symptoms will be assessed using the VEINES-Sym component of the Brazilian Portuguese version of the Venous Insufficiency Epidemiological and Economic Study Quality of Life/Symptoms questionnaire (VEINES-QOL/Sym). The VEINES-Sym score is derived from 10 items: the nine venous symptom items included in question 1 and the leg pain item included in question 7. The score will be calculated using intrinsic scoring. After orienting item responses so that higher values indicate a better health status, each item response will be transformed using (i-1)/(k-1), where i is the response category and k is the number of response categories for that item. The mean of the available transformed items will then be multiplied by 100. The VEINES-Sym score ranges from 0 to 100, with higher scores indicating fewer or less severe venous symptoms and a better symptom status. The score will not be calculated when more than 50% of the relevant items are missing. Change from baseline will be assessed at |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORCecília S Ulacia, MD
University of Sao Paulo
Outcome results
None listed