ENSAYO CLÍNICO MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO, PARALELO, COMPARADO CON PLACEBO PARA VALORAR LA EFICACIA DEL DOBESILATO CÁLCICO EN EL TRATAMIENTO DE LAS ÚLCERAS SECUNDARIAS A INSUFICIENCIA VENOSA CRÓNICA(RANDOMISED, MULTICENTRIC, DOUBLE BLIND, PARALLEL CLINICAL TRIAL, THAT ASSESS THE EFFICACY OF CALCIUM DOBESILATE COMPARED TO PLACEBO, IN THE TREATMENT OF SKIN ULCERS SECONDARIES TO CHRONIC VENOUS INSUFFICIENCY)
- Conditions
- Úlceras cutáneas secundarias a insuficiencia venosa crónica (Skin ulcers secondaries to chronic venous insufficiency)
- Registration Number
- EUCTR2007-002858-37-ES
- Lead Sponsor
- FUNDACIÓN IBEROAMERICANA ITACA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1) Pacients, both sexes, equal or bigger 18 years old
2) Pacients with venous ulcers (CEAP 6), stage I or II, between 3 and 50 cm2 of ulcers area
3) Ackle-arm index equal or bigger 0,9
4) Informed consent acceptation
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
1) Venous ulcer area lower than 3 cm2 and bigger than 50 cm2
2) Diabetes mellitus I or II
3) Ulcer stage III or IV
4) Illness that limit the performance of the study
5) Indication of leg revascularization surgery
6) Contraindication of compresives measures on the legs
7) Pregnancy
8) Lactation
9) Women with rejection to use anticonceptives methods during the study
10) Alergy o intolerance to phlebotonics
11) History of neutropenia or leucopenia
12) Basal leukocytes lower than 3 500 /ml
13) Patients with chronic renal failure on dialyse
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