PRP ULCERAS: Clinical Trial Phase III

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".

Conditions

• Ulcer

Interventions

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

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.

Sponsors & Collaborators

• Osakidetza

  collaborator OTHER

• Basque Health Service

  lead OTHER_GOV

Principal Investigators

• Kepa Mirena San Sebastian Moreno · C. Ezkerraldea Enkarterri.

• Igone Hernández Cabezas. · C. Ezkerraldea Enkarterri

• Igone Lobato García · C. Ezkerraldea Enkarterri

• Begoña Rodríguez Rodríguez. · C. Bilbao

• Ariadna Pérez Salvador · C. Ezkerraldea Enkarterri

• Gonzalo Grandes Odriozola · Primary Care Research Unit of Bizkaia

• Natalia Burgos Alonso. · Primary Care Research Unit of Bizkaia

• Anna Giné March · Primary Care Research Unit of Bizkaia

• Kepa Mirena San Sebastian Moreno · C. Ezkerraldea Enkarterri

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2016-12-31

Completion

2017-12-31

Countries

• Spain

Study Locations