Lower Limb Sclerotherapy of Reticular Veins and Telangiectasias

Sponsor

UPECLIN HC FM Botucatu Unesp (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05860439

Collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)

191

Enrollment

Location

76.9

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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 retiracular 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.

Condition or Disease	Intervention/Treatment	Phase
Telangiectasis	Procedure: Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)

Study Design

Study Type:

Observational

Anticipated Enrollment :

191 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Telangiectasias Relapse (Length) [730 days]

Secondary Outcome Measures

Hypercromia (Length) [730 days]
Matting (Length) [730 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.