Lower Limb Sclerotherapy of Reticular Veins and Telangiectasias

October 17, 2023 updated by: UPECLIN HC FM Botucatu Unesp

Long-term Follow-up of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

191

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Botucatu, SP, Brazil, 18607030
        • Sao Paulo State University Botucatu Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
730 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
730 days
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.
730 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UPECLIN HC FM Botucatu Unesp

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

May 5, 2023

First Submitted That Met QC Criteria

May 5, 2023

First Posted (Actual)

May 16, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPECLIN233283

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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