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Calcium Dobesilate for Chronic Venous Wounds

Primary Purpose

Ulcer

Status
Suspended
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Calcium Dobesilate
Sponsored by
Fundacion Iberoamericana Itaca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcer focused on measuring venous, ulcer, phlebotonic, calcium dobesilate, clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Cabueñes
  • Hospital Central de Asturias
  • Hospital Germans Tries i Pujol
  • Hospital Sant Jaume de Calella
  • CAP El Castell
  • Hospital General de Granollers
  • Consorci Hospitalari de Mataró
  • CAP Pineda de Mar
  • Corpotació Sanitària Parc Taulí
  • CAP Sitges
  • CAP El Remei
  • Hospital de Vic
  • CAP Doctor Guillermo Masriera i Guardiola
  • CAP Les Corts
  • CAP Gaudí
  • CAP Sagrada Familia
  • CAP Vila de Gràcia
  • EAP Sardenya
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Dos de Maig
  • CAP la Sagrera
  • CAPSE
  • ABS Encants
  • ABS Lesseps
  • CAP la Salut
  • CAP Barceloneta
  • CAP Vila Olímpica
  • CAP Albera Salut
  • Fundación Hospital de Alcorcón
  • Hospital de Getafe
  • Hospital Sant Joan de Reus
  • CAP Vila-Rodona
  • Hospital General de Albacete
  • CAP Joanic
  • Hospital Platon
  • Hospital Virgen de las Nieves
  • Hospital de Leon
  • Hospital San Pedro de Logroño
  • Hospital la Princesa
  • Hospital Clínico Universitario San Carlos
  • Complejo Hospitalario de Son Dureta
  • Hospital Clínico Universitario de Valladolid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Calcium Dobesilate

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Healed venous ulcers

Secondary Outcome Measures

Percentage of re-epithelization area (cm2)
Length of time to heal ulcers
Ulcer recurrence
Ulcer pain
Safety

Full Information

First Posted
September 17, 2009
Last Updated
February 16, 2011
Sponsor
Fundacion Iberoamericana Itaca
Collaborators
Laboratorios del Dr. Esteve, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT00979836
Brief Title
Calcium Dobesilate for Chronic Venous Wounds
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Suspended
Why Stopped
The financial support was withdrawn.
Study Start Date
April 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Fundacion Iberoamericana Itaca
Collaborators
Laboratorios del Dr. Esteve, S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcer
Keywords
venous, ulcer, phlebotonic, calcium dobesilate, clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Calcium Dobesilate
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo is a capsule with the same presence of experimental drug.
Intervention Type
Drug
Intervention Name(s)
Calcium Dobesilate
Other Intervention Name(s)
Doxium
Intervention Description
500 mg/ three times/day for 6 months (capsules)
Primary Outcome Measure Information:
Title
Healed venous ulcers
Time Frame
at 6 months of treatment
Secondary Outcome Measure Information:
Title
Percentage of re-epithelization area (cm2)
Time Frame
at 6 month of treatment
Title
Length of time to heal ulcers
Time Frame
during all the period of the study (12 months)
Title
Ulcer recurrence
Time Frame
at 12 month
Title
Ulcer pain
Time Frame
at 6 and 12 months
Title
Safety
Time Frame
during the study (12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moreno Carriles, Rosa Mª
Organizational Affiliation
Hospital La Princesa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Cabueñes
City
Gijon
State/Province
Asturias
ZIP/Postal Code
33394
Country
Spain
Facility Name
Hospital Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
Facility Name
Hospital Germans Tries i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Sant Jaume de Calella
City
Calella
State/Province
Barcelona
ZIP/Postal Code
08370
Country
Spain
Facility Name
CAP El Castell
City
Castelldefels
State/Province
Barcelona
ZIP/Postal Code
08660
Country
Spain
Facility Name
Hospital General de Granollers
City
Granollers
State/Province
Barcelona
ZIP/Postal Code
08402
Country
Spain
Facility Name
Consorci Hospitalari de Mataró
City
Mataró
State/Province
Barcelona
ZIP/Postal Code
08304
Country
Spain
Facility Name
CAP Pineda de Mar
City
Pineda de Mar
State/Province
Barcelona
ZIP/Postal Code
08397
Country
Spain
Facility Name
Corpotació Sanitària Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
CAP Sitges
City
Sitges
State/Province
Barcelona
ZIP/Postal Code
08870
Country
Spain
Facility Name
CAP El Remei
City
Vic
State/Province
Barcelona
ZIP/Postal Code
08500
Country
Spain
Facility Name
Hospital de Vic
City
Vic
State/Province
Barcelona
ZIP/Postal Code
08500
Country
Spain
Facility Name
CAP Doctor Guillermo Masriera i Guardiola
City
Vilassar de Mar
State/Province
Barcelona
ZIP/Postal Code
08340
Country
Spain
Facility Name
CAP Les Corts
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08015
Country
Spain
Facility Name
CAP Gaudí
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08025
Country
Spain
Facility Name
CAP Sagrada Familia
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08025
Country
Spain
Facility Name
CAP Vila de Gràcia
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08025
Country
Spain
Facility Name
EAP Sardenya
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Dos de Maig
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08025
Country
Spain
Facility Name
CAP la Sagrera
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08027
Country
Spain
Facility Name
CAPSE
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Facility Name
ABS Encants
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08041
Country
Spain
Facility Name
ABS Lesseps
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
902011040
Country
Spain
Facility Name
CAP la Salut
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
902011040
Country
Spain
Facility Name
CAP Barceloneta
City
Barcelona
State/Province
Cataluña
Country
Spain
Facility Name
CAP Vila Olímpica
City
Barcelona
State/Province
Cataluña
Country
Spain
Facility Name
CAP Albera Salut
City
Peralada
State/Province
Girona
ZIP/Postal Code
17491
Country
Spain
Facility Name
Fundación Hospital de Alcorcón
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital de Getafe
City
Getafe
State/Province
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
Hospital Sant Joan de Reus
City
Reus
State/Province
Tarragona
ZIP/Postal Code
43201
Country
Spain
Facility Name
CAP Vila-Rodona
City
Vilarrodona
State/Province
Tarragona
ZIP/Postal Code
43814
Country
Spain
Facility Name
Hospital General de Albacete
City
Albacete
ZIP/Postal Code
02006
Country
Spain
Facility Name
CAP Joanic
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Platon
City
Barcelona
Country
Spain
Facility Name
Hospital Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital de Leon
City
Leon
ZIP/Postal Code
24071
Country
Spain
Facility Name
Hospital San Pedro de Logroño
City
Logroño
ZIP/Postal Code
26006
Country
Spain
Facility Name
Hospital la Princesa
City
Madrid
ZIP/Postal Code
28005
Country
Spain
Facility Name
Hospital Clínico Universitario San Carlos
City
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
Complejo Hospitalario de Son Dureta
City
Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47005
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
33141449
Citation
Martinez-Zapata MJ, Vernooij RW, Simancas-Racines D, Uriona Tuma SM, Stein AT, Moreno Carriles RMM, Vargas E, Bonfill Cosp X. Phlebotonics for venous insufficiency. Cochrane Database Syst Rev. 2020 Nov 3;11(11):CD003229. doi: 10.1002/14651858.CD003229.pub4.
Results Reference
derived

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Calcium Dobesilate for Chronic Venous Wounds

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