Calcium Dobesilate for Chronic Venous Wounds

Study Overview
=================
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 measures) and calcium dobesilate will heal-up better than venous ulcers treated with standards measures (compressive measures) and placebo.

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

Conditions
-----------------
Ulcer

Intervention / Treatment
-----------------
* Drug: Calcium Dobesilate


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcium Dobesilate<br> | Drug: Calcium Dobesilate<br>* 500 mg/ three times/day for 6 months (capsules)<br>* Other names: Doxium;|
| Placebo Comparator: Placebo<br>The placebo is a capsule with the same presence of experimental drug. | Drug: Calcium Dobesilate<br>* 500 mg/ three times/day for 6 months (capsules)<br>* Other names: Doxium;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healed venous ulcers |  | at 6 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of re-epithelization area (cm2) |  | at 6 month of treatment | 
| Length of time to heal ulcers |  | during all the period of the study (12 months) | 
| Ulcer recurrence |  | at 12 month | 
| Ulcer pain |  | at 6 and 12 months | 
| Safety |  | during the study (12 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
venous, ulcer, phlebotonic, calcium dobesilate, clinical trial