lower limb varicose veins
Conditions
Interventions
In one limb will be applied the CLaCS technique: using a skin cooling device, NdYag 1064nm long pulse transdermal laser is applied to the lesion, parameters adjusted accordingly. Right after, in the s
Treated vein disappearance rate, in photo and b mode Ultrasound and, When there’s no complete disappearance, vessel internal diameter reduction rate measured on B mode ultrasound with orthostatic pati
Sclerosant agent volume an
D26.776.708.822
Sponsors
clinica dra anelise rodrigues
Instituto Circular
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: patients over 18 years old who signed the informe consent; patients with small varicosities associated or not to telangectasias, with similar distribution in both lower limbs, veins with internal diameter up to 1.5mm in B mode ultrasound, with no contraindications for any of the studied procedures
Exclusion criteria
Exclusion criteria: Personal history of local or sistemic alergic reaction after polidocanol injection; age under 18 years old; pregnancy/ puerperium/ breastfeeding; use of topic or sistemic drugs tha might induce skin hyperpigmentation (EG isotretinoin, retinoic acid); local tissue damage or infection; presence of insuficiency of pelvic, perforators or saphenous (great/small) veins connected to the studied area
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of skin hyperpigmentation after ClaCS and polidocanol foam sclerotherapy, 60 days after one single session, will be evaluated through pre and post procedure, by 2 independent observers, blinded for the studied groups, using as criteria thr hyperpigmentation presence/absence | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin tone dissimilarity at treated spot and adjacent area, through colorimetry; to do so, a precision Beley 8mm colorimeter will be used to compare skin in both treated and adjacent skin - the colorimeter uses the system L*a*b*, being L* luminosity, a* red/green values and b* blue/yellow values and the tone difference is given as delta E, variations higher than 1 are visible to the naked eye and will be used for data comparison;Vein disappearance rate evaluated by photo and B mode ultrasound In Cases where there’s no complete disappearance of the vein, internal vein diameter reduction in B mode ultrasound with standing patient will be used as parameter ;Sclerosant agent volume and number of vein punctures;Incidence of minor adverse events: scarring, cough, superficial thrombophlebitis, telngectatic matting, fainting, migraine, scotomas, micro trombectomy need. Incidence of major events: Chest pain, transient neurological abnormalities, unadvertised arterial puncture, tissue necrosis, deep venous thrombosis, pulmonary embolism;Pain intensity using visual analog pain scale after each treatment ;Patients overall satisfaction 30 and 60 days after treatment using aesthetic numeric analog scale (ana-scale) | — |
Countries
Brazil
Contacts
Public Contactclinica dra anelise rodrigues
Outcome results
None listed