Clinical trial NCT00979836: 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
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Ulcer
Keywords: venous
ulcer
phlebotonic
calcium dobesilate
clinical trial
Lead sponsor: Fundacion Iberoamericana Itaca
Sponsor class: OTHER
Collaborators: name: Laboratorios del Dr. Esteve, S.A.
First posted: 2009-09-18
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Healed venous ulcers
timeFrame: at 6 months of treatment
Secondary outcomes:
measure: Percentage of re-epithelization area (cm2)
timeFrame: at 6 month of treatment
measure: Length of time to heal ulcers
timeFrame: during all the period of the study (12 months)
measure: Ulcer recurrence
timeFrame: at 12 month
measure: Ulcer pain
timeFrame: at 6 and 12 months
measure: Safety
timeFrame: during the study (12 months)
Other outcomes:
Locations:
city: Gijon
country: Spain
facility: Hospital de Cabueñes
state: Asturias
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: Hospital Germans Tries i Pujol
state: Barcelona
city: Calella
country: Spain
facility: Hospital Sant Jaume de Calella
state: Barcelona
city: Castelldefels
country: Spain
facility: CAP El Castell
state: Barcelona
city: Granollers
country: Spain
facility: Hospital General de Granollers
state: Barcelona
city: Mataró
country: Spain
facility: Consorci Hospitalari de Mataró
state: Barcelona
city: Pineda de Mar
country: Spain
facility: CAP Pineda de Mar
state: Barcelona
city: Sabadell
country: Spain
facility: Corpotació Sanitària Parc Taulí
state: Barcelona
city: Sitges
country: Spain
facility: CAP Sitges
state: Barcelona
city: Vic
country: Spain
facility: CAP El Remei
state: Barcelona
city: Vic
country: Spain
facility: Hospital de Vic
state: Barcelona
city: Vilassar de Mar
country: Spain
facility: CAP Doctor Guillermo Masriera i Guardiola
state: Barcelona
city: Barcelona
country: Spain
facility: CAP Les Corts
state: Cataluña
city: Barcelona
country: Spain
facility: CAP Gaudí
state: Cataluña
city: Barcelona
country: Spain
facility: CAP Sagrada Familia
state: Cataluña
city: Barcelona
country: Spain
facility: CAP Vila de Gràcia
state: Cataluña
city: Barcelona
country: Spain
facility: EAP Sardenya
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Dos de Maig
state: Cataluña
city: Barcelona
country: Spain
facility: CAP la Sagrera
state: Cataluña
city: Barcelona
country: Spain
facility: CAPSE
state: Cataluña
city: Barcelona
country: Spain
facility: ABS Encants
state: Cataluña
city: Barcelona
country: Spain
facility: ABS Lesseps
state: Cataluña
city: Barcelona
country: Spain
facility: CAP la Salut
state: Cataluña
city: Barcelona
country: Spain
facility: CAP Barceloneta
state: Cataluña
city: Barcelona
country: Spain
facility: CAP Vila Olímpica
state: Cataluña
city: Peralada
country: Spain
facility: CAP Albera Salut
state: Girona
city: Alcorcón
country: Spain
facility: Fundación Hospital de Alcorcón
state: Madrid
city: Getafe
country: Spain
facility: Hospital de Getafe
state: Madrid
city: Reus
country: Spain
facility: Hospital Sant Joan de Reus
state: Tarragona
city: Vilarrodona
country: Spain
facility: CAP Vila-Rodona
state: Tarragona
city: Albacete
country: Spain
facility: Hospital General de Albacete
city: Barcelona
country: Spain
facility: CAP Joanic
city: Barcelona
country: Spain
facility: Hospital Platon
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Leon
country: Spain
facility: Hospital de Leon
city: Logroño
country: Spain
facility: Hospital San Pedro de Logroño
city: Madrid
country: Spain
facility: Hospital la Princesa
city: Madrid
country: Spain
facility: Hospital Clínico Universitario San Carlos
city: Mallorca
country: Spain
facility: Complejo Hospitalario de Son Dureta
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
Study officials:
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Moreno Carriles, Rosa Mª
role: PRINCIPAL_INVESTIGATOR
References:
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.