Status:
WITHDRAWN
PRP ULCERAS: Clinical Trial Phase III
Lead Sponsor:
Basque Health Service
Collaborating Sponsors:
Osakidetza
Conditions:
Ulcer
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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, s...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02213952
Start Date
January 1 2015
End Date
December 1 2017
Last Update
February 25 2020
Active Locations (2)
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1
Comarca Enkarterri Ezkerraldea
Portugalete, Bizakaia, Spain, 48920
2
UIAPB
Bilbao, Bizkaia, Spain, 48014