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.
Investigators
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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