Telangiectasis, Varicose Veins
Conditions
Keywords
telangiectasis, varicose veins, veins, glucose, sclerotherapy
Brief 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). 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.
Interventions
DRUGGlucose
Sclerotherapy of telangiectasis in one lower limb.
Sclerotherapy of telangiectasis in one lower limb.
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 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 .
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Extent of Telangiectasias | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Hyperpigmentation | 2 months | 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. |
| Number of Participants With Deep Venous Thrombosis (DVT) | 1 week | 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. |
Countries
Brazil
Participant flow
Pre-assignment details
Some patients (n=17) 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 17 more patients.
Participants by arm
| Arm | Count |
|---|---|
| Glucose 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
Glucose: Sclerotherapy of telangiectasis in one lower limb. | 57 |
| Polidocanol With Glucose 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
Polidocanol with Glucose: Sclerotherapy of telangiectasis in one lower limb. | 58 |
| Total | 115 |
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 | 58 Participants | 57 Participants | 115 Participants |
| Age, Continuous | 43.6 years STANDARD_DEVIATION 10 | 40.7 years STANDARD_DEVIATION 10 | 42.2 years STANDARD_DEVIATION 10 |
| Region of Enrollment Brazil | 58 Participants | 57 Participants | 115 Participants |
| Sex: Female, Male Female | 58 Participants | 57 Participants | 115 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 51 |
| other Total, other adverse events | 28 / 47 | 21 / 51 |
| serious Total, serious adverse events | 0 / 47 | 0 / 51 |
Outcome results
Primary
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
Time frame: 2 months
Population: Only one lower limb submited to the treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glucose | Change From Baseline in Extent of Telangiectasias | 57.24 percent of change negative values | Standard Deviation 22.69 |
| Polidocanol With Glucose | Change From Baseline in Extent of Telangiectasias | 76.08 percent of change negative values | Standard Deviation 18.63 |
Secondary
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.
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Glucose | Number of Participants With Deep Venous Thrombosis (DVT) | 0 Participants |
| Polidocanol With Glucose | Number of Participants With Deep Venous Thrombosis (DVT) | 0 Participants |
Secondary
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.
Time frame: 2 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Glucose | Skin Hyperpigmentation | 0.49 percentage of hyperpigmentation |
| Polidocanol With Glucose | Skin Hyperpigmentation | 0 percentage of hyperpigmentation |