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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001514-26 | Other Grant/Funding Number | UIAPB-PRPULCERAS-2014 |
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Without recruitment
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| Name | Class |
|---|---|
| Osakidetza | OTHER |
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INTRODUCTION: Vascular ulcers are an important pathology in the daily medical practice in all the assistance levels, and they have big repercussion referring to individual, social and labour levels, supposing a big consumption of human and material resources.The cure with autologous platelet rich plasma (autologous PRP) has demonstrated in different studies a decrease in the cicatrization time comparing to conventional methods in hospital levels, which becomes interesting contrasting its efficacy in primary care.
AIM:Evaluate the efficacy of the autologous PRP in the treatment of vascular ulcers, comparing to the conventional treatment ( cure with humid environment), in primary care patients with chronic venous insufficiency in C-6 degree (CEAP classification).
DESIGN: A study will be executed, which will consist in a randomized clinical test, multicentered, in parallel groups and opened. 150 patients suffering of venous vascular ulcers will be studied, who will be between the age of 40-100 years old, and who will be attached to 10 health centers. Variables for the identification, following, result and patient profile have been defined. Emphasize the variables of "ulcer area decreasing", "CIVIQ index", "% one cure per week".
Vascular ulcers are an important pathology in the daily medical practice in all the assistance levels, and they have big repercussion referring to individual, social and labour levels, supposing a big consumption of human and material resources.The cure with autologous platelet rich plasma (autologous PRP) has demonstrated in different studies a decrease in the cicatrization time comparing to conventional methods in hospital levels, which becomes interesting contrasting its efficacy in primary care.The aim of this study is to evaluate the efficacy of the autologous PRP in the treatment of vascular ulcers, comparing to the conventional treatment (cure with humid environment), in primary care patients with chronic venous insufficiency in C-6 degree (CEAP classification). It is a study which will consist in a randomized clinical test, multicentered, in parallel groups and opened 150 patients suffering of venous vascular ulcers will be studied. Variables for the identification, following, result and patient profile have been defined. Emphasize the variables of "ulcer area change", "CIVIQ index", "% one cure per week".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet-Rich Plasma | Experimental | Our goal is to evaluate the efficacy of the autologous Platelet-Rich Plasma (PRP) in the treatment of vascular ulcers, comparing to the conventional treatment (cure with humid environment), in primary care patients with chronic venous ulcer. |
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| Usual treatment | Active Comparator | Usual treatment: Patients in the control group will be treated according to Osakidetza recommendations of humid environment cure. The choice of material for the cure depends on the prior assessment of the wound and surrounding skin, appearance and amount of exudate and the presence or absence of signs of infection. These cures will be performed every 48-72 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet-Rich Plasma | Drug | For obtaining autologous PRP, will be drawn from 9-30 ml of blood of the patient in sterile tubes containing 4.5 ml of 3.8% sodium citrate. The tubes will be centrifuged for 8 min at 580 Gs to separate the different blood components according to density gradient. After centrifugation, we will aspire the PRP. We will add CaCl2 to the PRP (50l per ml of liquid plasma). While the plasma will get gelified, we will cure the ulcer with saline cleaning and mechanical removal. Then the ulcer will be covered with gelified PRP and a secondary dressing. This cure will be done each 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| ULCER SIZE CHANGE | Change from baseline at 9 weeks of the surface area of the ulcer, in cm2, measured using ImageJ software from the weekly the photographs of the wound. | Change from baseline at 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| QUALITY OF LIFE (INDEX CIVIQ) | Change of the CIVIQ SCORE. 20-item self-reported quality of life questionnaire scale called Chronic Venous disease quality of life Questionnaire-20 (CIVIQ-20) was created and validated in France in 1996,1 as a sensitive instrument to capture the key dimensions of quality of life (QoL) specifically impaired by chronic venous disease (CVD). Four dimensions of the CIVIQ-20 were identified: physical (4 items), psychological (9 items), social (3 items), and pain (4 items). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kepa Mirena San Sebastian Moreno | C. Ezkerraldea Enkarterri. | Principal Investigator |
| Igone Hernández Cabezas. | C. Ezkerraldea Enkarterri | Study Chair |
| Igone Lobato GarcÃa | C. Ezkerraldea Enkarterri | Study Chair |
| Begoña RodrÃguez RodrÃguez. | C. Bilbao | Study Chair |
| Ariadna Pérez Salvador | C. Ezkerraldea Enkarterri | Study Chair |
| Gonzalo Grandes Odriozola | Primary Care Research Unit of Bizkaia | Study Chair |
| Natalia Burgos Alonso. | Primary Care Research Unit of Bizkaia | Study Director |
| Anna Giné March | Primary Care Research Unit of Bizkaia | Study Director |
| Kepa Mirena San Sebastian Moreno | C. Ezkerraldea Enkarterri | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comarca Enkarterri Ezkerraldea | Portugalete | Bizakaia | 48920 | Spain | ||
| UIAPB |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25547983 | Derived | San Sebastian KM, Lobato I, Hernandez I, Burgos-Alonso N, Gomez-Fernandez MC, Lopez JL, Rodriguez B, March AG, Grandes G, Andia I. Efficacy and safety of autologous platelet rich plasma for the treatment of vascular ulcers in primary care: Phase III study. BMC Fam Pract. 2014 Dec 30;15:211. doi: 10.1186/s12875-014-0211-8. |
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| ID | Term |
|---|---|
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Usual treatment | Other | Usual treatment: Patients in the control group will be treated according to Osakidetza recommendations of humid environment cure. The choice of material for the cure depends on the prior assessment of the wound and surrounding skin, appearance and amount of exudate and the presence or absence of signs of infection. These cures will be performed every 48-72 hours. |
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| Change from baseline at 9 weeks |
| Change of the percentage OF PATIENTS WITH A ONLY ONE TREATMENT FOR WEEK | Change of the percentage OF PATIENTS WITH A ONLY ONE TREATMENT FOR WEEK | Change from baseline at 9 weeks |
| Bilbao |
| Bizkaia |
| 48014 |
| Spain |