Calcium Dobesilate for Chronic Venous Wounds

Fundacion Iberoamericana Itaca

Status and phase

Suspended

Phase 3

Conditions

Ulcer

Treatments

Drug: Calcium Dobesilate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00979836

2007-002858-37

Details and patient eligibility

About

The objective of the study is to assess the efficacy of calcium dobesilate for treating chronic venous wounds.

The hypothesis is that venous ulcers treated with standards measures (compressive measures) and calcium dobesilate will heal-up better than venous ulcers treated with standards measures (compressive measures) and placebo.

Enrollment

230 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with venous ulcer (CEAP 6) that affect epidermis, dermis and/or subcutaneous tissue, with and area superior to 3 cm2
Ankle-arm index 0.9 or superior
Written informed consent of the patients

Exclusion criteria

Patients with venous ulcer (CEAP 6) that affect bone or with and area inferior to 3 cm2
Ankle-arm index inferior to 0.9
No written informed consent of the patients
Diabetes mellitus I y II
Patients with renal failure and dialysis
Vascular surgery needed
Impossibility to use compressive measures on the leg
Use of topic antibiotics, silver dressing, growth factors, plasma-rich in platelets, skin graft, pentoxifylline, ultrasounds, laser, hyperbaric oxygen, electric stimulation o vacuum.
Pregnancy
Breast feeding
No anticonceptives measures
Allergy or intolerance to phebotonics
Background of neutropenia or leucopenia
Basal leucocytes < 3.500/ml