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

This study is currently recruiting participants.
Verified July 2013 by Basque Health Service
Sponsor:
Information provided by (Responsible Party):
Kepa M. San Sebastián Moreno, Basque Health Service
ClinicalTrials.gov Identifier:
NCT01817218
First received: February 27, 2013
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

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" .


Condition Intervention Phase
Chronic Vascular Ulcer
Biological: Platelet Rich Plasma
Device: "Antimicrobial debridin", "hydrocolloids", "alginates and hydrofibres", "polyurethane foams", "barrier products"
Phase 1
Phase 2

Study Type: Interventional
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

Further study details as provided by Basque Health Service:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 40
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)
Arms Assigned Interventions
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"

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 to 80 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01817218

Contacts
Contact: Kepa Mirena San Sebastian, Dr. kepamirena.sansebastianmoreno@osakidetza.net
Contact: Natalia Burgos-Alonso, Dr. 946006637 natalia.burgosalonso@osakidetza.net

Locations
Spain
Comarca Enkarterri Ezkerraldea Recruiting
Portugalete, Bizakaia, Spain, 48920
Contact: Natalia Burgos-Alonso, Dr.    003494006637    natalia.burgosalonso@osakidetza.net   
Contact: Maria Cruz Gomez, Dr.    003494006637    mariacruz.gomezfernandez@osakidetza.net   
Principal Investigator: Kepa Mirena San Sebastian, Doctor         
Sponsors and Collaborators
Basque Health Service
  More Information

No publications provided

Responsible Party: Kepa M. San Sebastián Moreno, Dr., Basque Health Service
ClinicalTrials.gov Identifier: NCT01817218     History of Changes
Other Study ID Numbers: 2012-002247-20
Study First Received: February 27, 2013
Last Updated: July 15, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Basque Health Service:
PRP
chronic vascular ulcer
primary care

Additional relevant MeSH terms:
Ulcer
Varicose Ulcer
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Alginic acid
Anti-Infective Agents
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014