Calcium Dobesilate for Chronic Venous Wounds

February 16, 2011 updated by: Fundacion Iberoamericana Itaca

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

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 Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

230

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Albacete, Spain, 02006
        • Hospital General de Albacete
      • Barcelona, Spain, 08025
        • CAP Joanic
      • Barcelona, Spain
        • Hospital Platon
      • Granada, Spain, 18014
        • Hospital Virgen de las Nieves
      • Leon, Spain, 24071
        • Hospital de Leon
      • Logroño, Spain, 26006
        • Hospital San Pedro de Logroño
      • Madrid, Spain, 28005
        • Hospital La Princesa
      • Madrid, Spain, 28905
        • Hospital Clinico Universitario San Carlos
      • Mallorca, Spain, 07014
        • Complejo Hospitalario de Son Dureta
      • Valladolid, Spain, 47005
        • Hospital Clinico Universitario de Valladolid
    • Asturias
      • Gijon, Asturias, Spain, 33394
        • Hospital de Cabueñes
      • Oviedo, Asturias, Spain, 33006
        • Hospital Central de Asturias
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Tries i Pujol
      • Calella, Barcelona, Spain, 08370
        • Hospital Sant Jaume de Calella
      • Castelldefels, Barcelona, Spain, 08660
        • Cap El Castell
      • Granollers, Barcelona, Spain, 08402
        • Hospital General de Granollers
      • Mataró, Barcelona, Spain, 08304
        • Consorci Hospitalari de Mataró
      • Pineda de Mar, Barcelona, Spain, 08397
        • CAP Pineda de Mar
      • Sabadell, Barcelona, Spain, 08208
        • Corpotació Sanitària Parc Taulí
      • Sitges, Barcelona, Spain, 08870
        • CAP Sitges
      • Vic, Barcelona, Spain, 08500
        • CAP El Remei
      • Vic, Barcelona, Spain, 08500
        • Hospital de Vic
      • Vilassar de Mar, Barcelona, Spain, 08340
        • CAP Doctor Guillermo Masriera i Guardiola
    • Cataluña
      • Barcelona, Cataluña, Spain, 08015
        • CAP les Corts
      • Barcelona, Cataluña, Spain, 08025
        • CAP Gaudí
      • Barcelona, Cataluña, Spain, 08025
        • CAP Sagrada Familia
      • Barcelona, Cataluña, Spain, 08025
        • CAP Vila de Gracia
      • Barcelona, Cataluña, Spain, 08025
        • EAP Sardenya
      • Barcelona, Cataluña, Spain, 08025
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Cataluña, Spain, 08025
        • Hospital dos de maig
      • Barcelona, Cataluña, Spain, 08027
        • CAP la Sagrera
      • Barcelona, Cataluña, Spain, 08036
        • CAPSE
      • Barcelona, Cataluña, Spain, 08041
        • ABS Encants
      • Barcelona, Cataluña, Spain, 902011040
        • ABS Lesseps
      • Barcelona, Cataluña, Spain, 902011040
        • CAP la Salut
      • Barcelona, Cataluña, Spain
        • CAP Barceloneta
      • Barcelona, Cataluña, Spain
        • CAP Vila Olimpica
    • Girona
      • Peralada, Girona, Spain, 17491
        • CAP Albera Salut
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Fundacion Hospital de Alcorcon
      • Getafe, Madrid, Spain, 28905
        • Hospital de Getafe
    • Tarragona
      • Reus, Tarragona, Spain, 43201
        • Hospital Sant Joan de Reus
      • Vilarrodona, Tarragona, Spain, 43814
        • CAP Vila-Rodona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calcium Dobesilate
Drug: Calcium Dobesilate
500 mg/ three times/day for 6 months (capsules)
Other Names:
  • Doxium
Placebo Comparator: Placebo
The placebo is a capsule with the same presence of experimental drug.
Drug: Calcium Dobesilate
500 mg/ three times/day for 6 months (capsules)
Other Names:
  • Doxium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Healed venous ulcers
Time Frame: at 6 months of treatment
at 6 months of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Iberoamericana Itaca

Collaborators

Laboratorios del Dr. Esteve, S.A.

Investigators

  • Principal Investigator: Moreno Carriles, Rosa Mª, Hospital La Princesa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

September 17, 2009

First Submitted That Met QC Criteria

September 17, 2009

First Posted (Estimate)

September 18, 2009

Study Record Updates

Last Update Posted (Estimate)

February 17, 2011

Last Update Submitted That Met QC Criteria

February 16, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-002858-37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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