Status:
SUSPENDED
Calcium Dobesilate for Chronic Venous Wounds
Lead Sponsor:
Fundacion Iberoamericana Itaca
Collaborating Sponsors:
Esteve Pharmaceuticals, S.A.
Conditions:
Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 measur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00979836
Start Date
April 1 2008
Last Update
February 17 2011
Active Locations (42)
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1
Hospital General de Albacete
Albacete, Albacete, Spain, 02006
2
Hospital Germans Tries i Pujol
Badalona, Barcelona, Spain, 08916
3
CAP Joanic
Barcelona, Barcelona, Spain, 08025
4
Hospital Sant Jaume de Calella
Calella, Barcelona, Spain, 08370