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

Primary Purpose

Chronic Ulcer

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Platelet Rich Plasma
Osakidetza protocol
Sponsored by
Basque Health Service
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Ulcer focused on measuring PRP, chronic vascular ulcer, primary care

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Comarca Enkarterri Ezkerraldea

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRP (Platelet Rich Plasma)

Osakidetza protocol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 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
REDUCTION IN ULCER SIZE
Difference in the area of the wound between week 9 and the first treatment session.
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.

Secondary Outcome Measures

Full Information

First Posted
February 27, 2013
Last Updated
July 22, 2015
Sponsor
Basque Health Service
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1. Study Identification

Unique Protocol Identification Number
NCT01817218
Brief Title
Feasibility and Safety and Evaluation of the Potential Efficacy of Autologous Platelet-rich Plasma in the Treatment of Vascular Venous Ulcers
Acronym
PRP-2012
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Basque Health Service

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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" .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Ulcer
Keywords
PRP, chronic vascular ulcer, primary care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRP (Platelet Rich Plasma)
Arm Type
Experimental
Arm Description
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.
Arm Title
Osakidetza protocol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Platelet Rich Plasma
Intervention Type
Device
Intervention Name(s)
Osakidetza protocol
Other Intervention Name(s)
"Antimicrobial debridin", "hydrocolloids", "alginates and hydrofibres", "polyurethane foams", "barrier products"
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of ULCER AREA
Description
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
Time Frame
Change from baseline at 9 weeks
Title
Change of the percentage OF PATIENTS WITH A ONLY ONE TREATMENT FOR WEEK
Description
Change of the percentage OF PATIENTS WITH A ONLY ONE TREATMENT FOR WEEK
Time Frame
Change from baseline at 9 weeks
Title
REDUCTION IN ULCER SIZE
Description
Difference in the area of the wound between week 9 and the first treatment session.
Time Frame
Change from baseline at 9 weeks
Title
Change of the CIVIQ SCORE
Description
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.
Time Frame
Change from baseline to 9th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kepa Mirena San Sebastian Moreno, Doctor
Organizational Affiliation
Osakidetza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comarca Enkarterri Ezkerraldea
City
Portugalete
State/Province
Bizakaia
ZIP/Postal Code
48920
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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