Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins
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| ClinicalTrials.gov Identifier: NCT02054325 |
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Recruitment Status :
Completed
First Posted : February 4, 2014
Results First Posted : January 27, 2017
Last Update Posted : January 27, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Varicose Veins | Drug: Polidocanol with Glucose Drug: Glucose | Phase 4 |
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. Reticular veins are those with less than 3mm diameter, bluish and important contribution to the aesthetic damage, and sometimes they are related to local pain and recurrence after treatment of telangiectasias. 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 69 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 reticular veins. The patients will be examined and clinically classified. It will be included patients with reticular veins sited at out's thigh/leg, measuring at least 10cm long, 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 reticular veins of the lower limbs. The results may help physicians to choose the best sclerotherapy treatment for reticular veins.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 106 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Triple-blind Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Sclerotherapy in Treatment of Reticular Veins at the Lower Limbs. |
| Study Start Date : | September 2012 |
| Actual Primary Completion Date : | December 2014 |
| Actual Study Completion Date : | December 2014 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Polidocanol with Glucose
An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.
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Drug: Polidocanol with Glucose
An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins 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
Other Names:
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Active Comparator: Glucose
An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.
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Drug: Glucose
An application session 75% Glucose to treat reticular veins 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
Other Name: Dextrose |
- Efficacy in Treating Reticular Veins by Photographs: Mean Percent Reticular Vein Disappearance Two Months After Treatment. [ Time Frame: Mean Percent of reticular vein disappearance two months after treatment ]Photographs were performed pretreatment and two months after the treatment, these were analyzed for efficacy in treat reticular veins by two blind analyzers objectively with measurement through the use of free software ImageJ.
- The Safety of the Treatment: Mean Percent of Skin Hyperpigmentation Two Months After Treatment [ Time Frame: Two months after treatment. ]Skin hyperpigmentation was defined as a brownish hue stain superimposing the previous treated vein site (by visual photographic analyses). Skin hyperpigmentation was firstly evaluated according to its occurence and labeled as "Yes" or "No". Afterwards, when there was stain in the previous treated area, a line was drawn on the stain with Image J software , and the Mean Percent of Skin Hyperpigmentation was proportionaly compared with length of vein treated, previuos mesuread (mean and SD).
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| Ages Eligible for Study: | 18 Years to 69 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- females
- with at least 10 cm from the lateral reticular veins of the leg or thigh of the leg
- clinical classification of chronic venous disease C1(mild venous disease),
- minimum age of 18 year-old and maximum age 69 year-old
- agreement with the study
- signing the free and informed consent ( IC)
- not use anticoagulant drugs .
Exclusion Criteria:
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054325
| Brazil | |
| School of Medicine at Botucatu- Paulista State University- UNESP, São Paulo, Brazil | |
| Botucatu, SP, Brazil, 18607030 | |
| Principal Investigator: | Matheus Bertanha, Professor | UPECLIN HC FM Botucatu Unesp |
| Responsible Party: | Dr Matheus Bertanha, Professor, UPECLIN HC FM Botucatu Unesp |
| ClinicalTrials.gov Identifier: | NCT02054325 |
| Other Study ID Numbers: |
CEP 4127.2012 |
| First Posted: | February 4, 2014 Key Record Dates |
| Results First Posted: | January 27, 2017 |
| Last Update Posted: | January 27, 2017 |
| Last Verified: | November 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | We intend to present data when publish the original article. |
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Sclerotherapy varicose veins veins |
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Varicose Veins Vascular Diseases Cardiovascular Diseases |
Polidocanol Sclerosing Solutions Pharmaceutical Solutions |