Úlceras cutáneas secundarias a insuficiencia venosa crónica (Skin ulcers secondaries to chronic venous insufficiency)
Conditions
Interventions
Trade Name: Doxium fuerte
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
FUNDACIÓN IBEROAMERICANA ITACA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of Doxium fuerte in total healing of venous ulcers;Secondary Objective: To evaluate secondaries outcomes of Doxium fuerte efficacy and his tolerance and advers effects;Primary end point(s): Total venous ulcer healing (100% of epithelization) | — |
Countries
Spain
Outcome results
None listed