Feasibility and Safety and Evaluation of the Potential Efficacy of Autologous Platelet-rich Plasma in the Treatment of Vascular Venous Ulcers (PRP-2012)
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 practicability, security and potential 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 pilot study will be executed, which will consist in a randomized clinical test, multicentred, in parallel groups and opened. 40 patients suffering of venous vascular ulcers will be studied, who will be between the age of 40-80 years old, and who will be attached to five 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" .
Chronic Vascular Ulcer
Biological: Platelet Rich Plasma
Device: "Antimicrobial debridin", "hydrocolloids", "alginates and hydrofibres", "polyurethane foams", "barrier products"
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasibility and Safety and Evaluation of the Potential Efficacy of Autologous Platelet-rich Plasma in the Treatment of Vascular Venous Ulcers Compared to Moist Wound Care in a Primary Care Setting|
- Change of ULCER AREA [ Time Frame: Change from baseline at 9 weeks ] [ Designated as safety issue: No ]Change from baseline at 9 weeks of the surface area of the ulcer, in cm3, measured using ImageJ software from the weekly the photographs of the wound
- Change of the percentage OF PATIENTS WITH A ONLY ONE TREATMENT FOR WEEK [ Time Frame: Change from baseline at 9 weeks ] [ Designated as safety issue: No ]Change of the percentage OF PATIENTS WITH A ONLY ONE TREATMENT FOR WEEK
- REDUCTION IN ULCER SIZE [ Time Frame: Change from baseline at 9 weeks ] [ Designated as safety issue: No ]Difference in the area of the wound between week 9 and the first treatment session.
- Change of the CIVIQ SCORE [ Time Frame: Change from baseline to 9th week ] [ Designated as safety issue: Yes ]change of the scale assessing quality of life of patients with chronic venous insufficiency, considering four dimensions (physical, psychological, social and pain) with a score ranging from 20 to 100, where 20 corresponds to the poorest quality of life and 100 to the best.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: PRP (Platelet Rich Plasma)
PRP treatment of vascular ulcers one a week PRP: a volume of 9-30 ml of blood will be collected from the patient (depending of the size of their ulcer) in sterile 4.5-ml tubes containing 3.8% sodium citrate, which will bind to the calcium ions, preventing clot formation we will add 50 μl of CaCl2 per ml liquid plasma. The extraction of the PRP fraction by sticking with a syringe and the adding of CaCl2 should be performed under sterile conditions.
|Biological: Platelet Rich Plasma|
Active Comparator: moist healing environment treatment
Patients in the control group will be treated following the recommendations of the Ezkerraldea-Enkarterri Health Region, that is, using a moist healing environment (as described in "Uso racional de los productos de cura en ambiente húmedo. Plan de formación continuada de Osakidetza", 2011).
The type of material used to treat and dress the wound will be chosen after the assessment of the wound and surrounding skin, type and quantity of exudate and whether there are signs of infection. Wound care will be carried out every 48-72 hours, as is the current usual practice.
|Device: "Antimicrobial debridin", "hydrocolloids", "alginates and hydrofibres", "polyurethane foams", "barrier products"|
|Contact: Kepa Mirena San Sebastian, Dr.||firstname.lastname@example.org|
|Contact: Natalia Burgos-Alonso, Dr.||email@example.com|
|Comarca Enkarterri Ezkerraldea||Recruiting|
|Portugalete, Bizakaia, Spain, 48920|
|Contact: Natalia Burgos-Alonso, Dr. 003494006637 firstname.lastname@example.org|
|Contact: Maria Cruz Gomez, Dr. 003494006637 email@example.com|
|Principal Investigator: Kepa Mirena San Sebastian, Doctor|