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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT00979836
Other study ID # 2007-002858-37
Secondary ID
Status Suspended
Phase Phase 3
First received September 17, 2009
Last updated February 16, 2011
Start date April 2008

Study information

Verified date February 2011
Source Fundacion Iberoamericana Itaca
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Suspended
Enrollment 230
Est. completion date
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Calcium Dobesilate
500 mg/ three times/day for 6 months (capsules)

Locations

Country Name City State
Spain Hospital General de Albacete Albacete
Spain Fundación Hospital de Alcorcón Alcorcón Madrid
Spain Hospital Germans Tries i Pujol Badalona Barcelona
Spain ABS Encants Barcelona Cataluña
Spain ABS Lesseps Barcelona Cataluña
Spain CAP Barceloneta Barcelona Cataluña
Spain CAP Gaudí Barcelona Cataluña
Spain CAP Joanic Barcelona
Spain CAP la Sagrera Barcelona Cataluña
Spain CAP la Salut Barcelona Cataluña
Spain CAP Les Corts Barcelona Cataluña
Spain CAP Sagrada Familia Barcelona Cataluña
Spain CAP Vila de Gràcia Barcelona Cataluña
Spain CAP Vila Olímpica Barcelona Cataluña
Spain CAPSE Barcelona Cataluña
Spain EAP Sardenya Barcelona Cataluña
Spain Hospital de la Santa Creu i Sant Pau Barcelona Cataluña
Spain Hospital Dos de Maig Barcelona Cataluña
Spain Hospital Platon Barcelona
Spain Hospital Sant Jaume de Calella Calella Barcelona
Spain CAP El Castell Castelldefels Barcelona
Spain Hospital de Getafe Getafe Madrid
Spain Hospital de Cabueñes Gijon Asturias
Spain Hospital Virgen de las Nieves Granada
Spain Hospital General de Granollers Granollers Barcelona
Spain Hospital de Leon Leon
Spain Hospital San Pedro de Logroño Logroño
Spain Hospital Clínico Universitario San Carlos Madrid
Spain Hospital la Princesa Madrid
Spain Complejo Hospitalario de Son Dureta Mallorca
Spain Consorci Hospitalari de Mataró Mataró Barcelona
Spain Hospital Central de Asturias Oviedo Asturias
Spain CAP Albera Salut Peralada Girona
Spain CAP Pineda de Mar Pineda de Mar Barcelona
Spain Hospital Sant Joan de Reus Reus Tarragona
Spain Corpotació Sanitària Parc Taulí Sabadell Barcelona
Spain CAP Sitges Sitges Barcelona
Spain Hospital Clínico Universitario de Valladolid Valladolid
Spain CAP El Remei Vic Barcelona
Spain Hospital de Vic Vic Barcelona
Spain CAP Vila-Rodona Vilarrodona Tarragona
Spain CAP Doctor Guillermo Masriera i Guardiola Vilassar de Mar Barcelona

Sponsors (2)

Lead Sponsor Collaborator
Fundacion Iberoamericana Itaca Laboratorios del Dr. Esteve, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Healed venous ulcers at 6 months of treatment No
Secondary Percentage of re-epithelization area (cm2) at 6 month of treatment No
Secondary Length of time to heal ulcers during all the period of the study (12 months) No
Secondary Ulcer recurrence at 12 month No
Secondary Ulcer pain at 6 and 12 months No
Secondary Safety during the study (12 months) Yes
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