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PRP ULCERAS: Clinical Trial Phase III (PRPULCERAS)

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ClinicalTrials.gov Identifier: NCT02213952
Recruitment Status : Unknown
Verified February 2017 by Kepa M. San Sebastián Moreno, Basque Health Service.
Recruitment status was:  Active, not recruiting
First Posted : August 12, 2014
Last Update Posted : March 1, 2017
Sponsor:
Collaborator:
Osakidetza
Information provided by (Responsible Party):
Kepa M. San Sebastián Moreno, Basque Health Service

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 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".


Condition or disease Intervention/treatment Phase
Ulcer Drug: Platelet-Rich Plasma Other: Usual treatment Phase 3

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Autologous Platelet-Rich Plasma in the Treatment of Vascular Ulcers in Primary Care: Clinical Trial Phase III
Actual Study Start Date : January 2015
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: Platelet-Rich Plasma
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.
Drug: Platelet-Rich Plasma
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.
Other Name: PRP

Active Comparator: Usual treatment
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.
Other: Usual treatment
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.
Other Name: Osakidetza protocol of humid environment cure.




Primary Outcome Measures :
  1. ULCER SIZE CHANGE [ Time Frame: Change from baseline at 9 weeks ]
    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.


Secondary Outcome Measures :
  1. QUALITY OF LIFE (INDEX CIVIQ) [ Time Frame: Change from baseline at 9 weeks ]
    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).

  2. Change of the percentage OF PATIENTS WITH A ONLY ONE TREATMENT FOR WEEK [ Time Frame: Change from baseline at 9 weeks ]
    Change of the percentage OF PATIENTS WITH A ONLY ONE TREATMENT FOR WEEK



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients from Barakaldo and Bilbao, who come to the treatment room at health centers in these towns belong to the OSI Ezkerraldea-Enkarterri-Cruces of Osakidetza-Basque Health Service.
  • Men or women older than 18 years old.
  • Patients with chronic venous insufficiency stage C-6 of the CEAP classification.
  • Patients with vascular ulcers unresponsive to conventional treatment over a 2 months period or recurrence of previous venous ulcers.
  • Patients who present an analytical before entering the studio, platelets and red blood cell count and hematocrit in normal range
  • Ulcers whose diameter size is 30cm² or less.
  • Greater Ankle Arm Index 0.8 and less than 1.5.
  • Patients with recent analytic with number platelet and red blood cell count and hematocrit normal range.
  • Patients with recent analytic negative to: Syphilis serology, Hepatitis B: HBsAg, Hepatitis C: Anti-HCV tests genomic nucleic acid amplification (NAT), HIV I / II: Anti-HIV I / II.
  • Self or family support sufficient to move patients to the health center.
  • Written informed consent of the patient

Exclusion Criteria:

  • Patients on chronic immunosuppressive or retroviral.
  • Coagulopathy
  • Patients with chronic infectious diseases.
  • Patients treated with radiotherapy or chemotherapy, or history of neoplasia.
  • Patients with more than two active ulcers.
  • Pregnant or childbearing potential not want to use contraception.
  • Women breastfeeding.
  • Patients with active infection or febrile syndrome at baseline.
  • People who are taking a drug under clinical investigation or participated in any study under clinical investigation in the previous 30 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213952


Locations
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Spain
Comarca Enkarterri Ezkerraldea
Portugalete, Bizakaia, Spain, 48920
UIAPB
Bilbao, Bizkaia, Spain, 48014
Sponsors and Collaborators
Basque Health Service
Osakidetza
Investigators
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Principal Investigator: Kepa Mirena San Sebastian Moreno C. Ezkerraldea Enkarterri.
Study Chair: Igone Hernández Cabezas. C. Ezkerraldea Enkarterri
Study Chair: Igone Lobato García C. Ezkerraldea Enkarterri
Study Chair: Begoña Rodríguez Rodríguez. C. Bilbao
Study Chair: Ariadna Pérez Salvador C. Ezkerraldea Enkarterri
Study Chair: Gonzalo Grandes Odriozola Primary Care Research Unit of Bizkaia
Study Director: Natalia Burgos Alonso. Primary Care Research Unit of Bizkaia
Study Director: Anna Giné March Primary Care Research Unit of Bizkaia
Principal Investigator: Kepa Mirena San Sebastian Moreno C. Ezkerraldea Enkarterri

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kepa M. San Sebastián Moreno, Physician, Basque Health Service
ClinicalTrials.gov Identifier: NCT02213952     History of Changes
Other Study ID Numbers: UIAPB-PRPULCERAS-2014-02
2014-001514-26 ( Other Grant/Funding Number: UIAPB-PRPULCERAS-2014 )
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Keywords provided by Kepa M. San Sebastián Moreno, Basque Health Service:
Ulcer
Platelet-Rich Plasma
Additional relevant MeSH terms:
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Ulcer
Pathologic Processes