Clinical trial NCT01817218: Feasibility and Safety and Evaluation of the Potential Efficacy of Autologous Platelet-rich Plasma in the Treatment of Vascular Venous Ulcers
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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Ulcer
Keywords: PRP
chronic vascular ulcer
primary care
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2013-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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" .


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.

Primary outcomes:
measure: Change of ULCER AREA
timeFrame: Change from baseline at 9 weeks
measure: Change of the percentage OF PATIENTS WITH A ONLY ONE TREATMENT FOR WEEK
timeFrame: Change from baseline at 9 weeks
measure: REDUCTION IN ULCER SIZE
timeFrame: Change from baseline at 9 weeks
measure: Change of the CIVIQ SCORE
timeFrame: Change from baseline to 9th week
Secondary outcomes:
Other outcomes:
Locations:
city: Portugalete
country: Spain
facility: Comarca Enkarterri Ezkerraldea
state: Bizakaia
Study officials:
affiliation: Osakidetza
name: Kepa Mirena San Sebastian Moreno, Doctor
role: PRINCIPAL_INVESTIGATOR
References: