Calcium Dobesilate for Chronic Venous Wounds

This study has suspended participant recruitment.
(The financial support was withdrawn.)
Sponsor:
Collaborator:
Laboratorios del Dr. Esteve, S.A.
Information provided by:
Fundacion Iberoamericana Itaca
ClinicalTrials.gov Identifier:
NCT00979836
First received: September 17, 2009
Last updated: February 16, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Ulcer
Drug: Calcium Dobesilate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fundacion Iberoamericana Itaca:

Primary Outcome Measures:
  • Healed venous ulcers [ Time Frame: at 6 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of re-epithelization area (cm2) [ Time Frame: at 6 month of treatment ] [ Designated as safety issue: No ]
  • Length of time to heal ulcers [ Time Frame: during all the period of the study (12 months) ] [ Designated as safety issue: No ]
  • Ulcer recurrence [ Time Frame: at 12 month ] [ Designated as safety issue: No ]
  • Ulcer pain [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: during the study (12 months) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 230
Study Start Date: April 2008
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcium Dobesilate Drug: Calcium Dobesilate
500 mg/ three times/day for 6 months (capsules)
Other Name: 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 Name: Doxium

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979836

Locations
Spain
Hospital de Cabueñes
Gijon, Asturias, Spain, 33394
Hospital Central de Asturias
Oviedo, Asturias, Spain, 33006
Hospital Germans Tries i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Sant Jaume de Calella
Calella, Barcelona, Spain, 08370
CAP El Castell
Castelldefels, Barcelona, Spain, 08660
Hospital General de Granollers
Granollers, Barcelona, Spain, 08402
Consorci Hospitalari de Mataró
Mataró, Barcelona, Spain, 08304
CAP Pineda de Mar
Pineda de Mar, Barcelona, Spain, 08397
Corpotació Sanitària Parc Taulí
Sabadell, Barcelona, Spain, 08208
CAP Sitges
Sitges, Barcelona, Spain, 08870
CAP El Remei
Vic, Barcelona, Spain, 08500
Hospital de Vic
Vic, Barcelona, Spain, 08500
CAP Doctor Guillermo Masriera i Guardiola
Vilassar de Mar, Barcelona, Spain, 08340
Hospital Dos de Maig
Barcelona, Cataluña, Spain, 08025
Hospital de la Santa Creu i Sant Pau
Barcelona, Cataluña, Spain, 08025
EAP Sardenya
Barcelona, Cataluña, Spain, 08025
CAP Vila de Gràcia
Barcelona, Cataluña, Spain, 08025
CAPSE
Barcelona, Cataluña, Spain, 08036
CAP Gaudí
Barcelona, Cataluña, Spain, 08025
CAP Sagrada Familia
Barcelona, Cataluña, Spain, 08025
CAP Les Corts
Barcelona, Cataluña, Spain, 08015
ABS Encants
Barcelona, Cataluña, Spain, 08041
ABS Lesseps
Barcelona, Cataluña, Spain, 902011040
CAP la Salut
Barcelona, Cataluña, Spain, 902011040
CAP Barceloneta
Barcelona, Cataluña, Spain
CAP Vila Olímpica
Barcelona, Cataluña, Spain
CAP la Sagrera
Barcelona, Cataluña, Spain, 08027
CAP Albera Salut
Peralada, Girona, Spain, 17491
Fundación Hospital de Alcorcón
Alcorcón, Madrid, Spain, 28922
Hospital de Getafe
Getafe, Madrid, Spain, 28905
Hospital Sant Joan de Reus
Reus, Tarragona, Spain, 43201
CAP Vila-Rodona
Vilarrodona, Tarragona, Spain, 43814
Hospital General de Albacete
Albacete, Spain, 02006
CAP Joanic
Barcelona, Spain, 08025
Hospital Platon
Barcelona, Spain
Hospital Virgen de las Nieves
Granada, Spain, 18014
Hospital de Leon
Leon, Spain, 24071
Hospital San Pedro de Logroño
Logroño, Spain, 26006
Hospital Clínico Universitario San Carlos
Madrid, Spain, 28905
Hospital la Princesa
Madrid, Spain, 28005
Complejo Hospitalario de Son Dureta
Mallorca, Spain, 07014
Hospital Clínico Universitario de Valladolid
Valladolid, Spain, 47005
Sponsors and Collaborators
Fundacion Iberoamericana Itaca
Laboratorios del Dr. Esteve, S.A.
Investigators
Principal Investigator: Moreno Carriles, Rosa Mª Hospital la Princesa
  More Information

No publications provided

Responsible Party: Mª JOSÉ MARTINEZ ZAPATA, Centro Cochrane Iberoamericano
ClinicalTrials.gov Identifier: NCT00979836     History of Changes
Other Study ID Numbers: 2007-002858-37
Study First Received: September 17, 2009
Last Updated: February 16, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundacion Iberoamericana Itaca:
venous
ulcer
phlebotonic
calcium dobesilate
clinical trial

Additional relevant MeSH terms:
Ulcer
Pathologic Processes
Calcium, Dietary
Calcium Dobesilate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 15, 2014