Calcium Dobesilate for Chronic Venous Wounds

Ulcer Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00979836
• Other study ID #: 2007-002858-37
• 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. 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

• Ulcer

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