Varicose VeinsPhase 4PG3TNCT02657252
Polidocanol Versus Glucose Treatment of Telangiectasia Trial
A Phase 4 study testing Glucose and Polidocanol with Glucose in people with Varicose Veins and Telangiectasis, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75% hypertonic glucose of sclerotherapy in lower limbs´ telangiectasis. It will be included only adult women with reticular veins on the side of the thighs and mild venous insufficiency (CEAP 1). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Varicose Veins, Telangiectasis
- What is being tested?
- Glucose and Polidocanol with Glucose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2015to Nov 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- females
- with telangiectasis on thigh side
- clinical classification of chronic venous disease C1(mild venous disease),
- minimum age of 18 year-old and maximum age 65 year-old
- agreement with the study
- signing the free and informed consent ( IC)
- not use anticoagulant drugs .
Who cannot join
- male
- varicose disease in any quantity or location with clinical classification of chronic venous disease different of C1(mild venous disease)
- restrict mobility
- arterial insufficiency
- be allergic to any substance that may be related to the study drugs
- any cause of dermatitis on application site
Show all 12Show fewer
- don´t be free of comorbidities clinically serious as diabetes mellitus, heart failure, respiratory failure, uncontrolled hypertension with medication, and uncontrolled hypothyroidism
- pregnancy
- previous deep vein thrombosis (DVT)
- family history of DVT
- thrombophilia
- do not agree with the search terms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Polidocanol Versus Glucose For Sclerotherapy Treatment Of Telangiectasia Of The Lower Limbs: Protocol For A Randomized, Controlled Clinical Trial
It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75% hypertonic glucose of sclerotherapy in lower limbs´ telangiectasis. It will be included only adult women with reticular veins on the side of the thighs and mild venous insufficiency (CEAP 1). The primary endpoint will be efficacy, and secondary will be safety.
Read the detailed description
Background. The prevalence of chronic venous disease is high in the general population, mainly in young women, and in milder cases the usual complaint is aesthetic. Various techniques are used for treatment of mild varicose disease, including surgical treatment, laser ablation and sclerotherapy. Telangiectasis are those with less than 1 mm diameter, reddish and important contribution to the aesthetic damage, and sometimes they are related to local pain. There is no consensus in the literature about the effectiveness of treatment with sclerotherapy, despite of being an usual procedure with different chemicals.
Methods and design. One hundred lower limbs of healthy women between 18 and 65 years will be triple blind randomized to receive treatment with polidocanol 0.2% diluted in 70% hypertonic glucose versus 75% hypertonic glucose for sclerotherapy treatment of telangiectasis. The patients will be examined and clinically classified. It will be included patients with telangiectasis sited at out's thigh, and only one extremity will be included per patient. The patients with varicose disease CEAP 2 or more will not be included. The treatment will be carried out in only one session and the medication volume not exceeding 5 ml. Clinical follow-up protocols will be filled on regular visits on days 0 - 7 - 60 concomitantly with photograph documentation. Supplementary examination for venous mapping with ultrasound pretreatment is performed for all patients.
Discussion. This prospective controlled double-blind randomized trial aims to verify and compare the efficacy and safety for sclerotherapy treatment of telangiectasis of the lower limbs. The results may help physicians to choose the best sclerotherapy treatment for telangiectasis.
- Conditions
- Varicose Veins, Telangiectasis
- Being tested
- Glucose, Polidocanol with Glucose
- Keywords
- telangiectasis, varicose veins, veins, glucose, sclerotherapy
- Medical subject headings
- Varicose Veins, Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoseDrug
Also called Hypertonic dextrose
Sclerotherapy of telangiectasis in one lower limb.
Polidocanol with GlucoseDrug
Also called Asclera, Varithena
Sclerotherapy of telangiectasis in one lower limb.
| Study group | Role | What they receive |
|---|---|---|
| Glucose | Active comparator | An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects Receives: Drug: Glucose |
| Polidocanol with Glucose | Active comparator | An application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects Receives: Drug: Polidocanol with Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Extent of Telangiectasias
Efficiency in promoting the disappearance of the treated telangiectasias, making the comparison between the initial measurements in centimeters and after two months, then comparing the treatment between the two treatments
Measured: 2 months
Secondary outcomes (2)
Skin Hyperpigmentation
Observed after two months of treatment the occurrence of hyperpigmentation stains in the treated areas. Measuring in centimeters those stains and compare the two treatments together.
Measured: 2 months
Number of Participants With Deep Venous Thrombosis (DVT)
Observe after one week of treatment occurred if clinical signs and symptoms of deep vein thrombosis (DVT) and perform duplex ultrasound for confirmation. Compare the results between the two groups to establish a security policy.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startJan 2015
- Primary completionSep 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 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
- Principal investigator, Dr Matheus Bertanha, UPECLIN HC FM Botucatu Unesp
- Investigators
- Matheus Bertanha, Dr, Principal investigator, Botucatu School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657252
- Sponsor's protocol ID
- UPECLIN
- Acronym
- PG3T
- Status last verified
- Nov 2017
- First submitted
- 7 Jan 2016
- Last updated
- 4 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Bertanha M, Camargo PA, Moura R, Yoshida WB, Pimenta RE, Mariuba JV, Alcantara GP, de Paula DR, Sobreira ML. Polidocanol versus glucose in the treatment of telangiectasia of the lower limbs (PG3T): Protocol for a randomized, controlled clinical trial. Medicine (Baltimore). 2016 Sep;95(39):e4812. doi: 10.1097/MD.0000000000004812.
PubMed 27684809
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polidocanol Versus Glucose For Sclerotherapy Treatment Of Telangiectasia Of The Lower Limbs: Protocol For A Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02657252
- Acronym / sponsor ID
- PG3T / UPECLIN
- Conditions
- Varicose Veins, Telangiectasis
- Keywords
- telangiectasis, varicose veins, veins, glucose, sclerotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 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
- Jan 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Posted 28 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75% hypertonic glucose of sclerotherapy in lower limbs´ telangiectasis. It will be included only adult women with reticular veins on the side of the thighs and mild venous insufficiency (CEAP 1). The primary endpoint will be efficacy, and secondary will be safety.
Detailed description
Background. The prevalence of chronic venous disease is high in the general population, mainly in young women, and in milder cases the usual complaint is aesthetic. Various techniques are used for treatment of mild varicose disease, including surgical treatment, laser ablation and sclerotherapy. Telangiectasis are those with less than 1 mm diameter, reddish and important contribution to the aesthetic damage, and sometimes they are related to local pain. There is no consensus in the literature about the effectiveness of treatment with sclerotherapy, despite of being an usual procedure with different chemicals.
Methods and design. One hundred lower limbs of healthy women between 18 and 65 years will be triple blind randomized to receive treatment with polidocanol 0.2% diluted in 70% hypertonic glucose versus 75% hypertonic glucose for sclerotherapy treatment of telangiectasis. The patients will be examined and clinically classified. It will be included patients with telangiectasis sited at out's thigh, and only one extremity will be included per patient. The patients with varicose disease CEAP 2 or more will not be included. The treatment will be carried out in only one session and the medication volume not exceeding 5 ml. Clinical follow-up protocols will be filled on regular visits on days 0 - 7 - 60 concomitantly with photograph documentation. Supplementary examination for venous mapping with ultrasound pretreatment is performed for all patients.
Discussion. This prospective controlled double-blind randomized trial aims to verify and compare the efficacy and safety for sclerotherapy treatment of telangiectasis of the lower limbs. The results may help physicians to choose the best sclerotherapy treatment for telangiectasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucose | Active comparator | Drug: GlucoseAn application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects |
| Polidocanol with Glucose | Active comparator | Drug: Polidocanol with GlucoseAn application session 0.2% Polidocanol + 70% Glucose to treat telangiectasis of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- females
- with telangiectasis on thigh side
- clinical classification of chronic venous disease C1(mild venous disease),
- minimum age of 18 year-old and maximum age 65 year-old
- agreement with the study
Key exclusion criteria (12 listed)
- male
- varicose disease in any quantity or location with clinical classification of chronic venous disease different of C1(mild venous disease)
- restrict mobility
- arterial insufficiency
- be allergic to any substance that may be related to the study drugs
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 |
|---|---|---|
| GlucoseAlso: Hypertonic dextroseSclerotherapy of telangiectasis in one lower limb. | Drug | Glucose |
| Polidocanol with GlucoseAlso: Asclera, VarithenaSclerotherapy of telangiectasis in one lower limb. | Drug | Polidocanol with Glucose |
Primary outcome
Change From Baseline in Extent of Telangiectasias
Time frame: 2 months
Efficiency in promoting the disappearance of the treated telangiectasias, making the comparison between the initial measurements in centimeters and after two months, then comparing the treatment between the two treatments
2 secondary outcomes
Skin Hyperpigmentation
Time frame: 2 months
Number of Participants With Deep Venous Thrombosis (DVT)
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27684809Bertanha M, Camargo PA, Moura R, Yoshida WB, Pimenta RE, Mariuba JV, Alcantara GP, de Paula DR, Sobreira ML. Polidocanol versus glucose in the treatment of telangiectasia of the lower limbs (PG3T): Protocol for a randomized, controlled clinical trial. Medicine (Baltimore). 2016 Sep;95(39):e4812. doi: 10.1097/MD.0000000000004812.
- Individual participant dataSharing planned: Yes
Related trials for Varicose Veins
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Not yet recruiting
Mindfulness Intervention on Minimally Invasive Vascular Surgery
Anxiety, Pain
Active, not recruitingObservational study
Pain During Heat Treatment for Lower Extremity Varicose Veins: Radiofrequency vs. Microwave
Lower Extremity Varicose Veins, Radiofrequency Ablation
Not yet recruiting
Phenotyping Rehabilitation for Improving Frailty, Functional Capacity
Varicose Veins
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.
Matheus Bertanha, Dr principal investigator
Botucatu School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucose and Polidocanol with Glucose in people with Varicose Veins and 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 7 inclusion and 12 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 4 Jan 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Extent of Telangiectasias (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02657252, which also lists 1 linked publication.
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 4 Jan 2018.