Calcium Dobesilate for Chronic Venous Wounds
This study has suspended participant recruitment.
(The financial support was withdrawn.)
Sponsor:
Fundacion Iberoamericana Itaca
Collaborator:
Laboratorios del Dr. Esteve, S.A.
Information provided by:
Fundacion Iberoamericana Itaca
ClinicalTrials.gov Identifier:
NCT00979836
First received: September 17, 2009
Last updated: February 16, 2011
Last verified: February 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ulcer |
Drug: Calcium Dobesilate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Calcium
Drug Information available for:
Calcium Gluconate
U.S. FDA Resources
Further study details as provided by Fundacion Iberoamericana Itaca:
Primary Outcome Measures:
- Healed venous ulcers [ Time Frame: at 6 months of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of re-epithelization area (cm2) [ Time Frame: at 6 month of treatment ] [ Designated as safety issue: No ]
- Length of time to heal ulcers [ Time Frame: during all the period of the study (12 months) ] [ Designated as safety issue: No ]
- Ulcer recurrence [ Time Frame: at 12 month ] [ Designated as safety issue: No ]
- Ulcer pain [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
- Safety [ Time Frame: during the study (12 months) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 230 |
| Study Start Date: | April 2008 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Calcium Dobesilate |
Drug: Calcium Dobesilate
500 mg/ three times/day for 6 months (capsules)
Other Name: Doxium
|
|
Placebo Comparator: Placebo
The placebo is a capsule with the same presence of experimental drug.
|
Drug: Calcium Dobesilate
500 mg/ three times/day for 6 months (capsules)
Other Name: Doxium
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979836
Locations
| Spain | |
| Hospital de Cabueñes | |
| Gijon, Asturias, Spain, 33394 | |
| Hospital Central de Asturias | |
| Oviedo, Asturias, Spain, 33006 | |
| Hospital Germans Tries i Pujol | |
| Badalona, Barcelona, Spain, 08916 | |
| Hospital Sant Jaume de Calella | |
| Calella, Barcelona, Spain, 08370 | |
| CAP El Castell | |
| Castelldefels, Barcelona, Spain, 08660 | |
| Hospital General de Granollers | |
| Granollers, Barcelona, Spain, 08402 | |
| Consorci Hospitalari de Mataró | |
| Mataró, Barcelona, Spain, 08304 | |
| CAP Pineda de Mar | |
| Pineda de Mar, Barcelona, Spain, 08397 | |
| Corpotació Sanitària Parc Taulí | |
| Sabadell, Barcelona, Spain, 08208 | |
| CAP Sitges | |
| Sitges, Barcelona, Spain, 08870 | |
| CAP El Remei | |
| Vic, Barcelona, Spain, 08500 | |
| Hospital de Vic | |
| Vic, Barcelona, Spain, 08500 | |
| CAP Doctor Guillermo Masriera i Guardiola | |
| Vilassar de Mar, Barcelona, Spain, 08340 | |
| Hospital Dos de Maig | |
| Barcelona, Cataluña, Spain, 08025 | |
| Hospital de la Santa Creu i Sant Pau | |
| Barcelona, Cataluña, Spain, 08025 | |
| EAP Sardenya | |
| Barcelona, Cataluña, Spain, 08025 | |
| CAP Vila de Gràcia | |
| Barcelona, Cataluña, Spain, 08025 | |
| CAPSE | |
| Barcelona, Cataluña, Spain, 08036 | |
| CAP Gaudí | |
| Barcelona, Cataluña, Spain, 08025 | |
| CAP Sagrada Familia | |
| Barcelona, Cataluña, Spain, 08025 | |
| CAP Les Corts | |
| Barcelona, Cataluña, Spain, 08015 | |
| ABS Encants | |
| Barcelona, Cataluña, Spain, 08041 | |
| ABS Lesseps | |
| Barcelona, Cataluña, Spain, 902011040 | |
| CAP la Salut | |
| Barcelona, Cataluña, Spain, 902011040 | |
| CAP Barceloneta | |
| Barcelona, Cataluña, Spain | |
| CAP Vila Olímpica | |
| Barcelona, Cataluña, Spain | |
| CAP la Sagrera | |
| Barcelona, Cataluña, Spain, 08027 | |
| CAP Albera Salut | |
| Peralada, Girona, Spain, 17491 | |
| Fundación Hospital de Alcorcón | |
| Alcorcón, Madrid, Spain, 28922 | |
| Hospital de Getafe | |
| Getafe, Madrid, Spain, 28905 | |
| Hospital Sant Joan de Reus | |
| Reus, Tarragona, Spain, 43201 | |
| CAP Vila-Rodona | |
| Vilarrodona, Tarragona, Spain, 43814 | |
| Hospital General de Albacete | |
| Albacete, Spain, 02006 | |
| CAP Joanic | |
| Barcelona, Spain, 08025 | |
| Hospital Platon | |
| Barcelona, Spain | |
| Hospital Virgen de las Nieves | |
| Granada, Spain, 18014 | |
| Hospital de Leon | |
| Leon, Spain, 24071 | |
| Hospital San Pedro de Logroño | |
| Logroño, Spain, 26006 | |
| Hospital Clínico Universitario San Carlos | |
| Madrid, Spain, 28905 | |
| Hospital la Princesa | |
| Madrid, Spain, 28005 | |
| Complejo Hospitalario de Son Dureta | |
| Mallorca, Spain, 07014 | |
| Hospital Clínico Universitario de Valladolid | |
| Valladolid, Spain, 47005 | |
Sponsors and Collaborators
Fundacion Iberoamericana Itaca
Laboratorios del Dr. Esteve, S.A.
Investigators
| Principal Investigator: | Moreno Carriles, Rosa Mª | Hospital la Princesa |
More Information
No publications provided
| Responsible Party: | Mª JOSÉ MARTINEZ ZAPATA, Centro Cochrane Iberoamericano |
| ClinicalTrials.gov Identifier: | NCT00979836 History of Changes |
| Other Study ID Numbers: | 2007-002858-37 |
| Study First Received: | September 17, 2009 |
| Last Updated: | February 16, 2011 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Fundacion Iberoamericana Itaca:
|
venous ulcer phlebotonic calcium dobesilate clinical trial |
Additional relevant MeSH terms:
|
Ulcer Pathologic Processes Calcium, Dietary Calcium Dobesilate Bone Density Conservation Agents Physiological Effects of Drugs |
Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013