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The financial support was withdrawn.
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| Name | Class |
|---|---|
| Esteve Pharmaceuticals, S.A. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium Dobesilate | Experimental |
| |
| Placebo | Placebo Comparator | The placebo is a capsule with the same presence of experimental drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Dobesilate | Drug | 500 mg/ three times/day for 6 months (capsules) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Healed venous ulcers | at 6 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moreno Carriles, Rosa Mª | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Albacete | Albacete | Albacete | 02006 | Spain | ||
| Hospital Germans Tries i Pujol |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33141449 | Derived | 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. |
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| at 12 month |
| Ulcer pain | at 6 and 12 months |
| Safety | during the study (12 months) |
| Badalona |
| Barcelona |
| 08916 |
| Spain |
| CAP Joanic | Barcelona | Barcelona | 08025 | Spain |
| Hospital Sant Jaume de Calella | Calella | Barcelona | 08370 | Spain |
| CAP El Castell | Castelldefels | Barcelona | 08660 | Spain |
| Hospital General de Granollers | Granollers | Barcelona | 08402 | Spain |
| Consorci Hospitalari de Mataró | Mataró | Barcelona | 08304 | Spain |
| CAP Pineda de Mar | Pineda de Mar | Barcelona | 08397 | Spain |
| Corpotació Sanitària Parc Taulí | Sabadell | Barcelona | 08208 | Spain |
| CAP Sitges | Sitges | Barcelona | 08870 | Spain |
| CAP El Remei | Vic | Barcelona | 08500 | Spain |
| Hospital de Vic | Vic | Barcelona | 08500 | Spain |
| CAP Doctor Guillermo Masriera i Guardiola | Vilassar de Mar | Barcelona | 08340 | Spain |
| CAP Les Corts | Barcelona | Catalonia | 08015 | Spain |
| CAP Gaudí | Barcelona | Catalonia | 08025 | Spain |
| CAP Sagrada Familia | Barcelona | Catalonia | 08025 | Spain |
| CAP Vila de Gràcia | Barcelona | Catalonia | 08025 | Spain |
| EAP Sardenya | Barcelona | Catalonia | 08025 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Catalonia | 08025 | Spain |
| Hospital Dos de Maig | Barcelona | Catalonia | 08025 | Spain |
| CAP la Sagrera | Barcelona | Catalonia | 08027 | Spain |
| CAPSE | Barcelona | Catalonia | 08036 | Spain |
| ABS Encants | Barcelona | Catalonia | 08041 | Spain |
| ABS Lesseps | Barcelona | Catalonia | 902011040 | Spain |
| CAP la Salut | Barcelona | Catalonia | 902011040 | Spain |
| CAP Barceloneta | Barcelona | Catalonia | Spain |
| CAP Vila Olímpica | Barcelona | Catalonia | Spain |
| CAP Albera Salut | Peralada | Girona | 17491 | Spain |
| Hospital de Leon | León | Leon | 24071 | Spain |
| Fundación Hospital de Alcorcón | Alcorcón | Madrid | 28922 | Spain |
| Hospital de Getafe | Getafe | Madrid | 28905 | Spain |
| Complejo Hospitalario de Son Dureta | Mallorca | Mallorca | 07014 | Spain |
| Hospital de Cabueñes | Gijón | Principality of Asturias | 33394 | Spain |
| Hospital Central de Asturias | Oviedo | Principality of Asturias | 33006 | Spain |
| Hospital Sant Joan de Reus | Reus | Tarragona | 43201 | Spain |
| CAP Vila-Rodona | Vilarrodona | Tarragona | 43814 | Spain |
| Hospital Clínico Universitario de Valladolid | Valladolid | Valladolid | 47005 | Spain |
| Hospital Platon | Barcelona | Spain |
| Hospital Virgen de las Nieves | Granada | 18014 | Spain |
| Hospital San Pedro de Logroño | Logroño | 26006 | Spain |
| Hospital la Princesa | Madrid | 28005 | Spain |
| Hospital Clínico Universitario San Carlos | Madrid | 28905 | Spain |
| ID | Term |
|---|---|
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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