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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended

Enrollment

230

participants targeted

Target at P25-P50 for phase_3

Geographic Reach

1 country

42 active sites

Status

suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed

1.5 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2009

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed

Last Updated

February 17, 2011

Status Verified

February 1, 2011

Enrollment Period

2.2 years

First QC Date

September 17, 2009

Last Update Submit

February 16, 2011

Conditions

Ulcer

Keywords

venousulcerphlebotoniccalcium dobesilateclinical trial

Outcome Measures

Primary Outcomes (1)

Healed venous ulcers
at 6 months of treatment

Secondary Outcomes (5)

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)

Study Arms (2)

Calcium Dobesilate

EXPERIMENTAL

Drug: Calcium Dobesilate

Placebo

PLACEBO COMPARATOR

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

Drug: Calcium Dobesilate

Interventions

Calcium DobesilateDRUG

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

Also known as: Doxium

Calcium DobesilatePlacebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Fundacion Iberoamericana Itacalead
Esteve Pharmaceuticals, S.A.collaborator

Study Sites (42)

Hospital General de Albacete

Albacete, Albacete, 02006, Spain

Location

Hospital Germans Tries i Pujol

Badalona, Barcelona, 08916, Spain

Location

CAP Joanic

Barcelona, Barcelona, 08025, Spain

Location

Hospital Sant Jaume de Calella

Calella, Barcelona, 08370, Spain

Location

CAP El Castell

Castelldefels, Barcelona, 08660, Spain

Location

Hospital General de Granollers

Granollers, Barcelona, 08402, Spain

Location

Consorci Hospitalari de Mataró

Mataró, Barcelona, 08304, Spain

Location

CAP Pineda de Mar

Pineda de Mar, Barcelona, 08397, Spain

Location

Corpotació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

CAP Sitges

Sitges, Barcelona, 08870, Spain

Location

CAP El Remei

Vic, Barcelona, 08500, Spain

Location

Hospital de Vic

Vic, Barcelona, 08500, Spain

Location

CAP Doctor Guillermo Masriera i Guardiola

Vilassar de Mar, Barcelona, 08340, Spain

Location

CAP Les Corts

Barcelona, Catalonia, 08015, Spain

Location

CAP Gaudí