Lower Limb Sclerotherapy of Reticular Veins and Telangiectasias

NCT ID: NCT05860439

Last Updated: 2023-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

191 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2023-06-01

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.

Detailed Description

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Conditions

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Telangiectasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Telangiectasias Group - Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)

Previously treated with PDHG, no new interventions were performed.

Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)

Intervention Type PROCEDURE

Patients previously treated were reassessed for long-term follow-up.

Telangiectasias Group - Hypertonic Glucose 75% (HG)

Previously treated with HG, no new interventions were performed.

No interventions assigned to this group

Reticular Veins Group (PG3T) - Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)

Previously treated with PDHG, no new interventions were performed.

Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)

Intervention Type PROCEDURE

Patients previously treated were reassessed for long-term follow-up.

Reticular Veins Group (PG3T) - Hypertonic Glucose 75% (HG)

Previously treated with HG, no new interventions were performed.

No interventions assigned to this group

Interventions

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Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)

Patients previously treated were reassessed for long-term follow-up.

Intervention Type PROCEDURE

Other Intervention Names

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Hypertonic Glucose 75% (HG)

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

UPECLIN HC FM Botucatu Unesp

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sao Paulo State University Botucatu Campus

Botucatu, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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UPECLIN233283

Identifier Type: -

Identifier Source: org_study_id

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