Lower Limb Sclerotherapy of Reticular Veins and Telangiectasias

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.

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Key information

Conditions

Telangiectasis Cardiovascular Diseases Hyperpigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Sao Paulo State University Botucatu Campus

Botucatu, São Paulo, 18607030, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

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

Other names: Hypertonic Glucose 75% (HG)

Primary outcomes

Length of Telangiectasias in Centimeters

Time frame: 730 days

Total length of telangiectasias at day 730 for comparison with day 60 and assessment of disease relapse.

Secondary outcomes

Length of Hyperchromia in Centimeters

Time frame: 730 days

Total length of hyperchromic stains at day 730 for comparison with day 60 and assessment of reversion.
Length of Matting in Centimeters

Time frame: 730 days

Total length of matting neovascularization at day 730 for comparison with day 60 and assessment of reversion.

Sponsors and collaborators

Lead sponsor

UPECLIN HC FM Botucatu Unesp

Other

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2023
Study completion: 2023
First posted: May 16, 2023
Registry last updated: Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed