Lower Limb Sclerotherapy of Reticular Veins and Telangiectasias

Completed

• Conditions: Telangiectasis
• Interventions: Procedure: Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)

• Registration Number: NCT05860439
• Lead Sponsor: UPECLIN HC FM Botucatu Unesp

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2023-05-01
• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-16
• Study Completion: 2023-06-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 191

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Reticular Veins Group (PG3T) - Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)	Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)	Previously treated with PDHG, no new interventions were performed.
Telangiectasias Group - Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)	Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)	Previously treated with PDHG, no new interventions were performed.

Primary Outcome Measures

Name	Time	Method
Length of Telangiectasias in Centimeters	730 days	Total length of telangiectasias at day 730 for comparison with day 60 and assessment of disease relapse.

Secondary Outcome Measures

Name	Time	Method
Length of Matting in Centimeters	730 days	Total length of matting neovascularization at day 730 for comparison with day 60 and assessment of reversion.
Length of Hyperchromia in Centimeters	730 days	Total length of hyperchromic stains at day 730 for comparison with day 60 and assessment of reversion.

Trial Locations

Locations (1)

Sao Paulo State University Botucatu Campus; 🇧🇷 Botucatu, SP, Brazil