- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00979836
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
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
-
-
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Albacete, Spain, 02006
- Hospital General de Albacete
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Barcelona, Spain, 08025
- CAP Joanic
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Barcelona, Spain
- Hospital Platon
-
Granada, Spain, 18014
- Hospital Virgen de las Nieves
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Leon, Spain, 24071
- Hospital de Leon
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Logroño, Spain, 26006
- Hospital San Pedro de Logroño
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Madrid, Spain, 28005
- Hospital La Princesa
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Madrid, Spain, 28905
- Hospital Clínico Universitario San Carlos
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Mallorca, Spain, 07014
- Complejo Hospitalario de Son Dureta
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Valladolid, Spain, 47005
- Hospital Clínico Universitario de Valladolid
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Asturias
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Gijon, Asturias, Spain, 33394
- Hospital de Cabueñes
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Oviedo, Asturias, Spain, 33006
- Hospital Central de Asturias
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Barcelona
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Badalona, Barcelona, Spain, 08916
- Hospital Germans Tries i Pujol
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Calella, Barcelona, Spain, 08370
- Hospital Sant Jaume de Calella
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Castelldefels, Barcelona, Spain, 08660
- Cap El Castell
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Granollers, Barcelona, Spain, 08402
- Hospital General de Granollers
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Mataró, Barcelona, Spain, 08304
- Consorci Hospitalari de Mataró
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Pineda de Mar, Barcelona, Spain, 08397
- CAP Pineda de Mar
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Sabadell, Barcelona, Spain, 08208
- Corpotació Sanitària Parc Taulí
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Sitges, Barcelona, Spain, 08870
- CAP Sitges
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Vic, Barcelona, Spain, 08500
- CAP El Remei
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Vic, Barcelona, Spain, 08500
- Hospital de Vic
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Vilassar de Mar, Barcelona, Spain, 08340
- CAP Doctor Guillermo Masriera i Guardiola
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-
Cataluña
-
Barcelona, Cataluña, Spain, 08015
- CAP Les Corts
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Barcelona, Cataluña, Spain, 08025
- CAP Gaudí
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Barcelona, Cataluña, Spain, 08025
- CAP Sagrada Familia
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Barcelona, Cataluña, Spain, 08025
- CAP Vila de Gràcia
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Barcelona, Cataluña, Spain, 08025
- EAP Sardenya
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Barcelona, Cataluña, Spain, 08025
- Hospital de La Santa Creu I Sant Pau
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Barcelona, Cataluña, Spain, 08025
- Hospital Dos de Maig
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Barcelona, Cataluña, Spain, 08027
- CAP la Sagrera
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Barcelona, Cataluña, Spain, 08036
- CAPSE
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Barcelona, Cataluña, Spain, 08041
- ABS Encants
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Barcelona, Cataluña, Spain, 902011040
- ABS Lesseps
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Barcelona, Cataluña, Spain, 902011040
- CAP la Salut
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Barcelona, Cataluña, Spain
- CAP Barceloneta
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Barcelona, Cataluña, Spain
- CAP Vila Olímpica
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Girona
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Peralada, Girona, Spain, 17491
- CAP Albera Salut
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Madrid
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Alcorcón, Madrid, Spain, 28922
- Fundacion Hospital de Alcorcon
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Getafe, Madrid, Spain, 28905
- Hospital de Getafe
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Tarragona
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Reus, Tarragona, Spain, 43201
- Hospital Sant Joan de Reus
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Vilarrodona, Tarragona, Spain, 43814
- CAP Vila-Rodona
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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
16 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
|
500 mg/ three times/day for 6 months (capsules)
Other Names:
|
Placebo Comparator: Placebo
The placebo is a capsule with the same presence of experimental drug.
|
500 mg/ three times/day for 6 months (capsules)
Other Names:
|
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)
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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
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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
Collaborators
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.
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
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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