TelangiectasisNCT05860439
Lower Limb Sclerotherapy of Reticular Veins and Telangiectasias
An observational study of Telangiectasis, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Telangiectasis
- What is being tested?
- Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)
- Type of treatment
- Surgery or procedure
- How many people
- 191 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2017to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Sao Paulo State University Botucatu Campus
Botucatu, São Paulo, 18607030
About this study
Official title: 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.
- Conditions
- Telangiectasis
- Being tested
- Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)
- Keywords
- Sclerotherapy, Veins, Telangiectasias, Hyperpigmentation
- Medical subject headings
- Telangiectasis, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)Procedure or surgery
Also called Hypertonic Glucose 75% (HG)
Patients previously treated were reassessed for long-term follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Telangiectasias Group - Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG) | Previously treated with PDHG, no new interventions were performed. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Telangiectasias in Centimeters
Total length of telangiectasias at day 730 for comparison with day 60 and assessment of disease relapse.
Measured: 730 days
Secondary outcomes (2)
Length of Hyperchromia in Centimeters
Total length of hyperchromic stains at day 730 for comparison with day 60 and assessment of reversion.
Measured: 730 days
Length of Matting in Centimeters
Total length of matting neovascularization at day 730 for comparison with day 60 and assessment of reversion.
Measured: 730 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Jan 2017
- Primary completion1 May 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelangiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860439
- Sponsor's protocol ID
- UPECLIN233283
- Status last verified
- Oct 2023
- First submitted
- 5 May 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Sclerotherapy of Reticular Veins and Telangiectasias
- ClinicalTrials.gov ID
- NCT05860439
- Acronym / sponsor ID
- UPECLIN233283
- Conditions
- Telangiectasis
- Keywords
- Sclerotherapy, Veins, Telangiectasias, Hyperpigmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Telangiectasias Group - Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG) | – | Procedure: Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)Previously treated with PDHG, no new interventions were performed. |
| 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) | – | Procedure: Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)Previously treated with PDHG, no new interventions were performed. |
| Reticular Veins Group (PG3T) - Hypertonic Glucose 75% (HG) | – | –Previously treated with HG, no new interventions were performed. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG)Also: Hypertonic Glucose 75% (HG)Patients previously treated were reassessed for long-term follow-up. | Procedure or surgery | Reticular Veins Group (PG3T) - Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG), Telangiectasias Group - Polidocanol 0,2% + Hypertonic Glucose 70% (PDHG) |
Primary outcome
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.
2 secondary outcomes
Length of Hyperchromia in Centimeters
Time frame: 730 days
Length of Matting in Centimeters
Time frame: 730 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Telangiectasis, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Telangiectasias in Centimeters (time frame: 730 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.