Feasibility and Safety and Evaluation of the Potential Efficacy of Autologous Platelet-rich Plasma in the Treatment of Vascular Venous Ulcers (PRP-2012)

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

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" .

Study Overview

• Status: Completed
• Conditions: Chronic Ulcer
• Intervention / Treatment: Drug: Platelet Rich Plasma; Device: Osakidetza protocol

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Spain
  • Bizakaia
    • Portugalete, Bizakaia, Spain, 48920
      • Comarca Enkarterri Ezkerraldea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients resident in Barakaldo, who are seen in treatment rooms at the Zaballa outpatient clinic or one of the following health centres: Zaballa, La Paz, Urban, or San Vicente, in the Ezkerraldea-Enkarterri Health Region of the Basque Health Service - Osakidetza.
• Men or women of 40 to100 years of age
• Patients with stage C6 chronic venous insufficiency according to the CEAP classification
• Patients with vascular ulcers which have not responded to conventional treatment in 2 to 6 months
• Patients who present an analytical before entering the study with a normal range of number of platelets, red blood cells and hematocrit
• An ulcer of 3-5 cm in diameter
• An ABI of greater than or equal to 0.8 or less than or equal to 1.5.
• Independent patients or with sufficient family support
• Patients have given written informed consent

Exclusion Criteria:

• Patients with chronic treatment with immunosuppressive or retroviral drugs
• Coagulopathies
• Patients with chronic infectious diseases
• Patients under radiotherapy or chemotherapy
• Patients with a history of neoplasia
• Patients with more than two active ulcers
• Pregnant women
• Patients with active cellulitis or fever
• An ABI of less than 0.8 or more than 1.5.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Platelet Rich Plasma
ACTIVE_COMPARATOR: Osakidetza protocol; 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: Osakidetza protocol; 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.; Other Names: "Antimicrobial debridin"; "hydrocolloids"; "alginates and hydrofibres"; "polyurethane foams"; "barrier products"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change of ULCER AREA	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 from baseline at 9 weeks
REDUCTION IN ULCER SIZE	Difference in the area of the wound between week 9 and the first treatment session.	Change from baseline at 9 weeks
Change of the CIVIQ SCORE	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.	Change from baseline to 9th week

Collaborators and Investigators

• Sponsor: Basque Health Service
• Investigators: Principal Investigator: Kepa Mirena San Sebastian Moreno, Doctor, Osakidetza

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): January 1, 2015
• Study Completion (ACTUAL): April 1, 2015

Study Registration Dates

• First Submitted: February 27, 2013
• First Submitted That Met QC Criteria: March 22, 2013
• First Posted (ESTIMATE): March 25, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 23, 2015
• Last Update Submitted That Met QC Criteria: July 22, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: primary care; PRP; chronic vascular ulcer
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Veins; Ulcer; Varicose Ulcer; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: 2012-002247-20