Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.|
- Efficacy in treating reticular veins in the lower limbs [ Time Frame: The primary endpoint will be evaluated in two months ] [ Designated as safety issue: No ]Photographs will be performed pretreatment and two months after the treatment, these will be analyzed for efficacy in treat reticular veins treated subjectively by two blind analyzers and objectively by another analyzer with measurement through the use of free software ImageJ
- The safety of the treatment will be evaluated [ Time Frame: One week of treatment and two months of treatment. ] [ Designated as safety issue: Yes ]Photographs will be performed pretreatment, a week after the treatment, and two months later. It will be performed clinical and photographic assessment of possible adverse effects.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
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.
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
Active Comparator: Glucose
An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02054325
|Contact: Matheus Bertanha, Professor||+55 14 email@example.com|
|Contact: Marcone L. Sobreira, Professor||+55 14 firstname.lastname@example.org|
|School of Medicine at Botucatu- Paulista State University- UNESP, São Paulo, Brazil||Recruiting|
|Botucatu, SP, Brazil, 18607030|
|Contact: Matheus Bertanha, Professor +55 14 38116305 email@example.com|
|Contact: Marcone L Sobreira, Professor +55 14 38116305 firstname.lastname@example.org|
|Principal Investigator: Matheus Bertanha, Professor|
|Principal Investigator:||Matheus Bertanha, Professor||UPECLIN HC FM Botucatu Unesp|