Lower Limb Sclerotherapy of Reticular Veins and Telangiectasias

NCT05860439 | Completed

• 1 other identifier: UPECLIN233283
• Study Type: observational
• Target: 191
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Telangiectasis

Keywords

Sclerotherapy; Veins; Telangiectasias; Hyperpigmentation

Outcome Measures

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.

  730 days

Secondary Outcomes (2)

• Length of Hyperchromia in Centimeters

  730 days

• Length of Matting in Centimeters

  730 days

Study Arms (4)

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

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

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

Also known as: Hypertonic Glucose 75% (HG)

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• UPECLIN HC FM Botucatu Unesp: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Sao Paulo State University Botucatu Campus

Botucatu, São Paulo, 18607030, Brazil

Location

MeSH Terms

Conditions

Telangiectasis; Hyperpigmentation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 16, 2023
• Study Start: January 1, 2017
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)