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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-001514-26
    Sponsor's Protocol Code Number:UIAPB-PRPULCERAS-2014
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-09
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-001514-26
    A.3Full title of the trial
    Efficacy of Autologous Platelet-Rich Plasma in the treatment of vascular ulcers in Primary Care: Clinical trial phase III.
    Eficacia del Plasma Rico en Plaquetas autólogo en el tratamiento de úlceras vasculares en Atención Primaria: Ensayo clínico fase III.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Check the efficacy of PRP in vascular ulcers in primary care.
    Comprobar la eficacia del uso de PRP en úlceras vasculares en Atención Primaria.
    A.3.2Name or abbreviated title of the trial where available
    PRP in vascular ulcers in Primary Care
    PRP en ulceras vascular en Atención Primaria
    A.4.1Sponsor's protocol code numberUIAPB-PRPULCERAS-2014
    A.5.4Other Identifiers
    Name:UIAPBNumber:UIAPB-PRPULCERAS-2014
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorComarca Ezkerraldea-Enkarterri (OSAKIDETZA)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportComarca Ezkerraldea-Enkarterri (OSAKIDETZA)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnidad de investigacion de atencion Primaria de Bizakaia
    B.5.2Functional name of contact pointNatalia Burgos Alonso
    B.5.3 Address:
    B.5.3.1Street Addressc/Luis Power 18 4ªplanta
    B.5.3.2Town/ cityBilbao
    B.5.3.3Post code48014
    B.5.3.4CountrySpain
    B.5.4Telephone number0034946006637
    B.5.5Fax number0034946006639
    B.5.6E-mailnatalia.burgosalonso@osakidetza.net
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePRP autologo
    D.3.2Product code PRP AP
    D.3.4Pharmaceutical form Cutaneous patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Intraarticular use
    Intralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPRP 2012
    D.3.9.1CAS number 46465
    D.3.9.2Current sponsor codePRP 2012
    D.3.9.3Other descriptive namePLATELETS
    D.3.9.4EV Substance CodeSUB25592
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150.000 to 400.000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Yes
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with venous leg ulcers, between 40-100 years old, assigned to ten health centers in the county Ezkerraldea-Enkarterri Osakidetza Basque Health Service.
    Pacientes con úlceras vasculares venosas, entre 40-100 años de edad y adscritos a diez centros de salud de la Comarca Ezkerraldea-Enkarterri de Osakidetza, Servicio Vasco de Salud.
    E.1.1.1Medical condition in easily understood language
    Patients with cronic ulcers.
    Pacientes con ulceras cronicas.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level HLT
    E.1.2Classification code 10040796
    E.1.2Term Skin and subcutaneous tissue ulcerations
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficiency associated with autologous PRP estimating the reduction in ulcer area by assessing serial photographs at baseline, one month of treatment and two months after the start of treatment, compared with that observed in the control group.
    To evaluate the efficiency associated with autologous PRP estimating the reduction in ulcer area by evaluating serial photographs at baseline, one-month treatment and two-months treatment, compared with that observed in the control group.
    E.2.2Secondary objectives of the trial
    Evaluate the autologous PRP safety in the treatment of venous ulcers in patients with chronic venous insufficiency (stage C-6 in APEC classification), describing the reduction of pain of patients, the percentage of ulcers with infections, perilesional involvement, all in two groups and performing the comparison.

    Estimating the quality of life of patients by CIVIQ index in both groups at baseline, one month of treatment and two months of treatment.
    Evaluar la seguridad PRP autólogo en el tratamiento de las úlceras venosas en pacientes con insuficiencia venosa crónica (estadío C-6 de la clasificación la CEAP), describiendo la reducción del dolor en los pacientes, el porcentaje de úlceras con infecciones, afectación perilesional, todo ello en ambos grupos y realizando la comparación entre ellos.

    Estimar la calidad de vida del paciente mediante el Índice CIVIQ en ambos grupos en el momento basal, al mes de tratamiento y a los dos meses de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    •Pacientes que acudan a sala de curas de los centros de salud de esta s localidades,
    pertenecientes a la Comarca Sanitaria de Ezkerraldea-Enkarterri de Osakidetza-Servicio Vasco de Salud.
    •Hombres o mujeres con edad superior a 40 años y menor de 100 años.
    •Pacientes con insuficiencia venosa crónica estadio C-6 de la clasificación de la CEAP.
    •Pacientes con úlcera vascular que no responden a tratamiento convencional durante un periodo superior a 2
    meses.
    •Pacientes que presenten una analítica antes de entrar en el estudio, con número de plaquetas y número de
    glóbulos rojos y hematocrito en rango normal , y negativa a Sífilis: pruebas serológicas, Hepatitis B: AgHBs, Hepatitis
    C: Anti-VHC y pruebas de amplificación genómica del ácido nucleico (NAT), VIH I/II: Anti -VIH I/II.
    •Una o dos ulceras cuya area en conjunto sea igual o menor a 20 cm².
    •Índice Tobillo Brazo mayor de 0.8 y menor de 1.5.
    •Pacientes autónomos o con suficiente apoyo familiar para poder desplazarse al Centro de salud.
    •Consentimiento informado por escrito del paciente
    E.4Principal 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.
    • Pacientes en tratamiento crónico con inmunosupresores o retrovirales .
    • Coagulopatías.
    • Pacientes con enfermedades infecciosas crónicas: Sífilis, Hepatitis B, Hepatitis C, VIH.
    • Pacientes en tratamiento con radioterapia o quimioterapia.
    • Pacientes con historia de neoplasia.
    • Pacientes con más de dos úlceras activas.
    • Mujeres en periodo de lactancia o en edad fértil que no deseen usar medidas anticonceptivas eficaces
    durante el ensayo clínico.
    • Pacientes con infección activa o síndrome febril al inicio del estudio.
    • Pacientes con ITB menor de 0.8 o mayor de 1.5.
    • Personas que esten tomando un fármaco en fase de investigación clínica o hayan participado en algun
    estudio enfase de investigación clínica en los 30 días previos.
    E.5 End points
    E.5.1Primary end point(s)
    ULCER SIZE CHANGE
    QUALITY OF LIFE (INDEX CIVIQ)
    SAFETY
    PAIN (EVA)
    CAMBIO DEL TAMAÑO ULCERAL
    CALIDAD DE VIDA (INDICE CIVIQ)
    SEGURIDAD
    DOLOR (EVA)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Basal, 5th week and 9th week.
    The holding period of each patient will be 9 weeks, plus a systematic review of the medical records of the study participants at two years to detect possible long-term side effects related to carcinogenicity.
    Basal, 5ª semana y 9ª semana.
    El período de participación de cada paciente será de 9 semanas, habiendo además una revisión sistemática de las historias clínicas de los participantes en el estudio a los dos años para detectar posibles reacciones adversas a largo plazo relacionadas con la carcinogenicidad.
    E.5.2Secondary end point(s)
    AT-RISK OCCUPATION
    BODY WEIGHT
    HEIGHT
    BMI
    HISTORY OF THROMBOSIS
    TROPHIC LESION
    CAUSE OF THE LESION
    DISEASE COURSE
    PERIOD OF CONVENTIONAL
    TREATMENT
    COMPRESSION THERAPY
    PHLEBOTROPIC DRUGS
    PREVIOUS LESIONS
    SITE OF THE ULCER
    DIABETES
    ANKLE BRACHIAL INDEX
    TYPE OF DEBRIDEMENT
    NON-VIABLE TISSUE
    INFECTION
    PAIN
    WOUND EDGE
    LEG OEDEMA
    WOUND LENGTH
    WOUND WIDTH
    AMOUNT OF BLOOD TAKEN
    HEALING TIME
    NUMBER OF TREATMENT SESSIONS
    CHANGE PRIMARY DRESSING
    CHANGE SECONDARY DRESSING
    PROFESIÓN DE RIESGO
    PESO CORPORAL
    ALTURA
    IMC
    ANTECEDENTES DE TROMBOSIS
    LESION TRÓFICA
    CAUSA DE LA LESIÓN
    CURSO DE LA ENFERMEDAD
    PERIODO DE CONVENCIONALES
    E.5.2.1Timepoint(s) of evaluation of this end point
    Basal, 5th week and 9th week.
    The holding period of each patient will be 9 weeks, plus a systematic review of the medical records of the study participants at two years to detect possible long-term side effects related to carcinogenicity.
    Basal, 5ª semana y 9ª semana.
    El período de participación de cada paciente será de 9 semanas, habiendo además una revisión sistemática de las historias clínicas de los participantes en el estudio a los dos años para detectar posibles reacciones adversas a largo plazo relacionadas con la carcinogenicidad.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    tratamietno habitual
    Standar care
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The last test will be held after 9 weeks of the inclusion of the last patient, plus a systematic review of the medical records of the study participants at two years to detect possible long-term side effects related to carcinogenicity.
    La ultima prueba se realizara despues de 9 semanas de la inclusion del ultimo, habiendo además una revisión sistemática de las historias clínicas de los participantes en el estudio a los dos años para detectar posibles reacciones adversas a largo plazo relacionadas con la carcinogenicidad.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standar care
    Tratamiento habitual
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-25
    P. End of Trial
    P.End of Trial StatusCompleted
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