Calcium Dobesilate for Chronic Venous Wounds

Phase 3

Suspended

• Conditions: Ulcer
• Interventions: Drug: Calcium Dobesilate

• Registration Number: NCT00979836
• Lead Sponsor: Fundacion Iberoamericana Itaca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-09-17
• Study First Submitted QC: 2009-09-17
• Study First Posted: 2009-09-18
• Primary Completion: 2010-07
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-16
• Last Update Posted: 2011-02-17

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 230

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Calcium Dobesilate	The placebo is a capsule with the same presence of experimental drug.
Calcium Dobesilate	Calcium Dobesilate	-

Primary Outcome Measures

Name	Time	Method
Healed venous ulcers	at 6 months of treatment

Secondary Outcome Measures

Name	Time	Method
Percentage of re-epithelization area (cm2)	at 6 month of treatment
Length of time to heal ulcers	during all the period of the study (12 months)
Ulcer pain	at 6 and 12 months
Safety	during the study (12 months)
Ulcer recurrence	at 12 month

Trial Locations

Locations (42)

Hospital de Cabueñes; 🇪🇸 Gijon, Asturias, Spain

Hospital Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Hospital Germans Tries i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital Sant Jaume de Calella; 🇪🇸 Calella, Barcelona, Spain

CAP El Castell; 🇪🇸 Castelldefels, Barcelona, Spain

Hospital General de Granollers; 🇪🇸 Granollers, Barcelona, Spain

Consorci Hospitalari de Mataró; 🇪🇸 Mataró, Barcelona, Spain

CAP Pineda de Mar; 🇪🇸 Pineda de Mar, Barcelona, Spain

Corpotació Sanitària Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

CAP Sitges; 🇪🇸 Sitges, Barcelona, Spain

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