Lower Limb Sclerotherapy of Reticular Veins and Telangiectasias

Study Overview
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Brief Summary
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A long-term follow-up cohort study of patients that were assigned in two previous studies to compare the clinical results of sclerotherapy of telangiectasias and reticular veins of lower limbs using 0.2% polidocanol diluted in 70% hypertonic glucose (PDHG) vs 75% hypertonic glucose (HG) alone. All women, previously treated as aforementioned, were invited to be reevaluated regarding late maintenance and pigmentation over two years of follow-up. No new treatments were applied to the cohort.

Official Title
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Long-term Follow-up of Sclerotherapy of Reticular Veins and Telangiectasias

Conditions
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Telangiectasis

Intervention / Treatment
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* Procedure: Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients that concluded the participation of 60 days in both primary studies were invited to reevaluate the actual status of treatment (maintenance of treated vessels) and late complications (pigmentation and matting). Exclusion Criteria: Patients who did not agree to be reassessed; Patients who were not found after all available forms of contact had been tried; Patients who went through any kind of intervention on the area of interest in lower limbs between the end of the intervention and the reevaluation for long-term follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Telangiectasias Group - Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)<br>Previously treated with PDHG, no new interventions were performed. | Procedure: Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)<br>* Patients previously treated were reassessed for long-term follow-up.<br>* Other names: Hypertonic Glucose 75% (HG);|
| Telangiectasias Group - Hypertonic Glucose 75% (HG)<br>Previously treated with HG, no new interventions were performed. | |
| Reticular Veins Group (PG3T) - Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)<br>Previously treated with PDHG, no new interventions were performed. | Procedure: Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)<br>* Patients previously treated were reassessed for long-term follow-up.<br>* Other names: Hypertonic Glucose 75% (HG);|
| Reticular Veins Group (PG3T) - Hypertonic Glucose 75% (HG)<br>Previously treated with HG, no new interventions were performed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Telangiectasias in Centimeters | Total length of telangiectasias at day 730 for comparison with day 60 and assessment of disease relapse. | 730 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hyperchromia in Centimeters | Total length of hyperchromic stains at day 730 for comparison with day 60 and assessment of reversion. | 730 days | 
| Length of Matting in Centimeters | Total length of matting neovascularization at day 730 for comparison with day 60 and assessment of reversion. | 730 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sclerotherapy, Veins, Telangiectasias, Hyperpigmentation