Trial | NCT00979836  Report issue

Title

Calcium Dobesilate for Chronic Venous Wounds
Randomized, Double-blind Multicenter Clinical Trial Comparing the Efficacy of Calcium Dobesilate With Placebo in the Treatment of Ulcer Secondaries to Chronic Venous Disease

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Suspended

  • Indication/Condition

    Ulcer

  • Intervention/Treatment

    hydroquinone ...

  • Study Participants

    230
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.
Study Started
Apr 30
2008
Primary Completion
Jul 31
2010
Last Update
Feb 17
2011
Estimate

Drug Calcium Dobesilate

500 mg/ three times/day for 6 months (capsules)

  • Other names: Doxium

Calcium Dobesilate Experimental

Placebo Placebo Comparator

The placebo is a capsule with the same presence of experimental drug.

Criteria 

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
No Results Posted