Randomised controlled clinical trial to evaluate the efficacy of a sodium salicylate hydroglyceric solution used at different concentrations in the aesthetic and functional sclerotherapy of veins, venulae and ecstatic capillaries. - ND
- Conditions
- Patients with ecstatic vessels in inferior limbsMedDRA version: 6.1Level: HLGTClassification code 10057165
- Registration Number
- EUCTR2004-005147-10-IT
- Lead Sponsor
- KORPO S.R.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Male and female patients aged between 18 and 75 years, fair phototype, with injuries at inferior limbs, diameter of the injuries less than 8 mm.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients with a saphenous vein failure; b deep venous obstruction; c varicose veins; d dermathosis; e obesity BMI 30 Kg/m2 ; f individual hypersensitivity to the investigational medicinal product or to one of the eccipients; g serious nervous, cardiovascular, liver, kidney and gastrointestinal diseases; h pregnancy or breastfeeding; i hormones therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method