UlcerPhase 3NCT00979836
Calcium Dobesilate for Chronic Venous Wounds
A Phase 3 study testing Calcium Dobesilate in people with Ulcer, run by Fundacion Iberoamericana Itaca at 42 sites in Spain.
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcer
- What is being tested?
- Calcium Dobesilate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 42 sitesSpain
- Study dates
- Apr 2008to Jul 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
Spain42 sites
Hospital General de Albacete
Albacete, Albacete, 02006
Fundación Hospital de Alcorcón
Alcorcón, Madrid, 28922
Hospital Germans Tries i Pujol
Badalona, Barcelona, 08916
CAP Joanic
Barcelona, Barcelona, 08025
CAP Les Corts
Barcelona, Catalonia, 08015
CAP Gaudí
Barcelona, Catalonia, 08025
CAP Sagrada Familia
Barcelona, Catalonia, 08025
CAP Vila de Gràcia
Barcelona, Catalonia, 08025
EAP Sardenya
Barcelona, Catalonia, 08025
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08025
Hospital Dos de Maig
Barcelona, Catalonia, 08025
CAP la Sagrera
Barcelona, Catalonia, 08027
CAPSE
Barcelona, Catalonia, 08036
ABS Encants
Barcelona, Catalonia, 08041
ABS Lesseps
Barcelona, Catalonia, 902011040
CAP la Salut
Barcelona, Catalonia, 902011040
CAP Barceloneta
Barcelona, Catalonia
CAP Vila Olímpica
Barcelona, Catalonia
Hospital Platon
Barcelona
Hospital Sant Jaume de Calella
Calella, Barcelona, 08370
CAP El Castell
Castelldefels, Barcelona, 08660
Hospital de Getafe
Getafe, Madrid, 28905
Hospital de Cabueñes
Gijón, Principality of Asturias, 33394
Hospital Virgen de las Nieves
Granada, 18014
Hospital General de Granollers
Granollers, Barcelona, 08402
Hospital de Leon
León, Leon, 24071
Hospital San Pedro de Logroño
Logroño, 26006
Hospital la Princesa
Madrid, 28005
Hospital Clínico Universitario San Carlos
Madrid, 28905
Complejo Hospitalario de Son Dureta
Mallorca, Mallorca, 07014
Consorci Hospitalari de Mataró
Mataró, Barcelona, 08304
Hospital Central de Asturias
Oviedo, Principality of Asturias, 33006
CAP Albera Salut
Peralada, Girona, 17491
CAP Pineda de Mar
Pineda de Mar, Barcelona, 08397
Hospital Sant Joan de Reus
Reus, Tarragona, 43201
Corpotació Sanitària Parc Taulí
Sabadell, Barcelona, 08208
CAP Sitges
Sitges, Barcelona, 08870
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, 47005
CAP El Remei
Vic, Barcelona, 08500
Hospital de Vic
Vic, Barcelona, 08500
CAP Vila-Rodona
Vilarrodona, Tarragona, 43814
CAP Doctor Guillermo Masriera i Guardiola
Vilassar de Mar, Barcelona, 08340
About this study
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
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.
- Conditions
- Ulcer
- Being tested
- Calcium Dobesilate
- Keywords
- venous, ulcer, phlebotonic, calcium dobesilate, clinical trial
- Medical subject headings
- Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium DobesilateDrug
Also called Doxium
500 mg/ three times/day for 6 months (capsules)
| Study group | Role | What they receive |
|---|---|---|
| Calcium Dobesilate | Experimental | Not described Receives: Drug: Calcium Dobesilate |
| Placebo | Placebo comparator | The placebo is a capsule with the same presence of experimental drug. Receives: Drug: Calcium Dobesilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healed venous ulcers
Measured: at 6 months of treatment
Secondary outcomes (5)
Percentage of re-epithelization area (cm2)
Measured: at 6 month of treatment
Length of time to heal ulcers
Measured: during all the period of the study (12 months)
Ulcer recurrence
Measured: at 12 month
Ulcer pain
Measured: at 6 and 12 months
Safety
Measured: during the study (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startApr 2008
- Primary completionJul 2010
Why it stopped: The financial support was withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Iberoamericana Itaca
- Sponsor type
- University, hospital or other
- Collaborators
- Esteve Pharmaceuticals, S.A.
- Investigators
- Moreno Carriles, Rosa Mª, Principal investigator, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979836
- Sponsor's protocol ID
- 2007-002858-37
- Status last verified
- Feb 2011
- First submitted
- 17 Sep 2009
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33141449
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00979836
- Acronym / sponsor ID
- 2007-002858-37
- Conditions
- Ulcer
- Keywords
- venous, ulcer, phlebotonic, calcium dobesilate, clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The financial support was withdrawn.
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Fundacion Iberoamericana ItacaUniversity, hospital or other
- Collaborators
- Esteve Pharmaceuticals, S.A.
- Study start
- Apr 2008
- Primary completion
- Jul 2010 (actual)
- First posted
- 18 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium Dobesilate | Experimental | Drug: Calcium Dobesilate |
| Placebo | Placebo comparator | Drug: Calcium DobesilateThe placebo is a capsule with the same presence of experimental drug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium DobesilateAlso: Doxium500 mg/ three times/day for 6 months (capsules) | Drug | Calcium Dobesilate, Placebo |
Primary outcome
Healed venous ulcers
Time frame: at 6 months of treatment
5 secondary outcomes
Percentage of re-epithelization area (cm2)
Time frame: at 6 month of treatment
Length of time to heal ulcers
Time frame: during all the period of the study (12 months)
Ulcer recurrence
Time frame: at 12 month
Ulcer pain
Time frame: at 6 and 12 months
Safety
Time frame: during the study (12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2011.
- Derived from this study: PubMed 33141449Martinez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moreno Carriles, Rosa Mª principal investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Calcium Dobesilate in people with Ulcer, run by Fundacion Iberoamericana Itaca at 42 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 17 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healed venous ulcers (time frame: at 6 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00979836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2011; AzTrials last refreshed its copy on 2 Nov 2026.