Varicose Veins
Conditions
Keywords
Sclerotherapy, varicose veins, veins
Brief summary
It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75% hypertonic glucose of sclerotherapy in lower limbs´ reticular veins. 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. 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.
Interventions
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
DRUGGlucose
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
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
UPECLIN HC FM Botucatu Unesp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 69 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy in Treating Reticular Veins by Photographs: Mean Percent Reticular Vein Disappearance Two Months After Treatment. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Safety of the Treatment: Mean Percent of Skin Hyperpigmentation Two Months After Treatment | 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). |
Countries
Brazil
Participant flow
Pre-assignment details
Some patients (n=6) were withdrawn because did not appear at the previous scheduled appointments, and were replaced for new ones. In order to avoid loss of individuals we have decided to include 6 more patients.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 | 43 |
| Glucose An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.
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 | 50 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 5 |
Baseline characteristics
| Characteristic | Polidocanol With Glucose | Glucose | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 50 Participants | 93 Participants |
| Gender Female | 43 Participants | 50 Participants | 93 Participants |
| Gender Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 43 | 31 / 50 |
| serious Total, serious adverse events | 0 / 43 | 0 / 50 |
Outcome results
Primary
Efficacy in Treating Reticular Veins by Photographs: Mean Percent 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.
Time frame: Mean Percent of reticular vein disappearance two months after treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Polidocanol With Glucose | Efficacy in Treating Reticular Veins by Photographs: Mean Percent Reticular Vein Disappearance Two Months After Treatment. | 95.17 % of Reticular Veins that Disappeared | Standard Deviation 9.09 |
| Glucose | Efficacy in Treating Reticular Veins by Photographs: Mean Percent Reticular Vein Disappearance Two Months After Treatment. | 85.40 % of Reticular Veins that Disappeared | Standard Deviation 17.04 |
Secondary
The Safety of the Treatment: Mean Percent of Skin Hyperpigmentation 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).
Time frame: Two months after treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Polidocanol With Glucose | The Safety of the Treatment: Mean Percent of Skin Hyperpigmentation Two Months After Treatment | 5.75 Percent of Skin Hyperpigmentation | Standard Deviation 7.02 |
| Glucose | The Safety of the Treatment: Mean Percent of Skin Hyperpigmentation Two Months After Treatment | 9.66 Percent of Skin Hyperpigmentation | Standard Deviation 11.67 |