Status:
COMPLETED
Feasibility and Safety and Evaluation of the Potential Efficacy of Autologous Platelet-rich Plasma in the Treatment of Vascular Venous Ulcers
Lead Sponsor:
Basque Health Service
Conditions:
Chronic Ulcer
Eligibility:
All Genders
40+ years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01817218
Start Date
June 1 2013
End Date
April 1 2015
Last Update
July 23 2015
Active Locations (1)
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1
Comarca Enkarterri Ezkerraldea
Portugalete, Bizakaia, Spain, 48920