Check the efficacy of PRP in vascular ulcers in primary care.

Phase 1

• Conditions: Patients with venous leg ulcers, between 40-100 years old, assigned to ten health centers in the county Ezkerraldea-Enkarterri Osakidetza Basque Health Service.; MedDRA version: 17.1Level: HLTClassification code 10040796Term: Skin and subcutaneous tissue ulcerationsSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-001514-26-ES
• Lead Sponsor: Comarca Ezkerraldea-Enkarterri (OSAKIDETZA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-09
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients attending treatment room health centers this s localities,
belonging to the Sanitary District of Ezkerraldea-Enkarterri Osakidetza-Basque Health Service.
• Men and women older than 40 and younger than 100 years old.
• Patients with chronic venous insufficiency stage C-6 of the CEAP classification.
• Patients with vascular ulcers unresponsive to conventional treatment for a longer than 2
months period.
• Patients who present an analytical with a normal platelet count and number of serological tests, Hepatitis B: HBsAg, Hepatitis Syphilis negative red blood cells and hematocrit in normal range, and C: Anti-HCV testing genomic amplification and nucleic acid (NTA), HIV I / II: Anti-HIV I / II.
• One or two together ulcers whose area is equal to or less than 20 cm².
• Ankle Arm index greater than 0.8 and less than 1.5.
• self-sufficient family support or to scroll to the health center patients.
• written informed consent from the patient
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

• Patients on chronic immunosuppressive or retrovirals.
• Coagulopathies.
• Patients with chronic infectious diseases: Syphilis, Hepatitis B, Hepatitis C, HIV.
• Patients treated with radiotherapy or chemotherapy.
• Patients with history of neoplasia.
• Patients with more than two active ulcers.
• Women are breastfeeding or of childbearing age who do not wish to use effective contraception
during the clinical trial.
• Patients with active infection or febrile syndrome at baseline.
• Patients with ABI less than 0.8 or greater than 1.5.
• People who are taking a drug undergoing clinical investigation or have been involved in some
phasing plug clinical research study in the previous 30 days.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified