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CompletedNCT05860439Updated Oct 18, 2023

Lower Limb Sclerotherapy of Reticular Veins and Telangiectasias

An observational study in Telangiectasis, sponsored by UPECLIN HC FM Botucatu Unesp. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-10-18.

Sponsored by UPECLIN HC FM Botucatu Unesp · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
191
Ages
18 Years to 90 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Telangiectasis

Keywords

  • Sclerotherapy
  • Veins
  • Telangiectasias
  • Hyperpigmentation
03

In context

Telangiectasis

69 studies on the registry are indexed under Telangiectasis; 12 are open to participants now.

Browse Telangiectasis studies →

Lead sponsor

UPECLIN HC FM Botucatu Unesp is the lead sponsor of 65 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women between 18 and 90 years, with lower limb telangiectasias or reticular veins treated in previous studies with polidocanol plus hypertonic glucose or hypertonic glucose.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
191 participants (actual)
Patient registry
No

Groups and cohorts

  • 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)

  • 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)

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

    Previously treated with HG, no new interventions were performed.

Interventions

  • ProcedurePolidocanol 0,2% + Hypertonic Glucose 70% (PDHG)

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

    Also known as: Hypertonic Glucose 75% (HG)

06

What researchers measure

Primary outcomes

  1. Length of Telangiectasias in Centimeters

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

    Time frame: 730 days

Secondary outcomes

  1. Length of Hyperchromia in Centimeters

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

    Time frame: 730 days

  2. Length of Matting in Centimeters

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

    Time frame: 730 days

07

Study locations

1 site
  • Sao Paulo State University Botucatu Campus
    Botucatu, SP 18607030, Brazil
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05860439
Lead sponsor
UPECLIN HC FM Botucatu Unesp
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Responsible party
Sponsor
First posted
May 16, 2023
Start date
Jan 1, 2017
Primary completion
May 1, 2023
Completion
Jun 1, 2023
Last update
Oct 18, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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