Lower Limb Sclerotherapy of Reticular Veins and Telangiectasias

Telangiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05860439
• Other study ID #: UPECLIN233283
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: June 1, 2023

Study information

• Verified date: October 2023
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: June 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Telangiectasis

Intervention

Procedure:
• Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)
Patients previously treated were reassessed for long-term follow-up.

Locations

Country	Name	City	State
Brazil	Sao Paulo State University Botucatu Campus	Botucatu	SP

Sponsors (2)

Lead Sponsor	Collaborator
UPECLIN HC FM Botucatu Unesp	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of Hyperchromia in Centimeters	Total length of hyperchromic stains at day 730 for comparison with day 60 and assessment of reversion.	730 days
Secondary	Length of Matting in Centimeters	Total length of matting neovascularization at day 730 for comparison with day 60 and assessment of reversion.	730 days