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Clinical Trials/EUCTR2014-001514-26-ES
EUCTR2014-001514-26-ES
Active, not recruiting
Phase 1

Efficacy of Autologous Platelet-Rich Plasma in the treatment of vascular ulcers in Primary Care: Clinical trial phase III. - PRP in vascular ulcers in Primary Care

Comarca Ezkerraldea-Enkarterri (OSAKIDETZA)0 sites150 target enrollmentJune 9, 2014

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Comarca Ezkerraldea-Enkarterri (OSAKIDETZA)
Enrollment
150
Status
Active, not recruiting
Last Updated
7 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 9, 2014
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Comarca Ezkerraldea-Enkarterri (OSAKIDETZA)

Eligibility Criteria

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.

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\.

Outcomes

Primary Outcomes

Not specified

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