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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2017-000314-29
    Sponsor's Protocol Code Number:HULP2016-001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-03-31
    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 number2017-000314-29
    A.3Full title of the trial
    RANDOMIZED STUDY TO CHECK THE EFFECTIVENESS OF TOPICAL TREATMENT WITH PLATELET- RICH PLASMA IN THE HEALING OF LOWER LIMBS' VENOUS CHRONIC ULCERS
    ESTUDIO ALEATORIZADO PARA COMPROBAR LA EFECTIVIDAD DEL TRATAMIENTO TÓPICO CON PLASMA RICO EN PLAQUETAS EN LA CICATRIZACIÓN DE ÚLCERAS CRÓNICAS VENOSAS DE MIEMBROS INFERIORES
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the effectiveness in the healing of chronic venous leg ulcers of rich in platelets plasma treatment.
    Ensayo clínico para evaluar la efectividad en la cicatrización de úlceras venosas crónicas en piernas del tratamiento con plasma rico en plaquetas.
    A.3.2Name or abbreviated title of the trial where available
    PULCRO
    PULCRO
    A.4.1Sponsor's protocol code numberHULP2016-001
    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 SponsorServicio de Angiología y cirugía vascular. Hospital Universitario La Paz
    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 supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnidad Central de Ensayos Clínicos
    B.5.2Functional name of contact pointUCICEC
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number0034912071466
    B.5.6E-mailhoi.tong@idipaz.es
    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 namePRGF Endoret
    D.3.4Pharmaceutical form Concentrate for cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    Topical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPlatelet-Rich Plasma
    D.3.9.2Current sponsor codeBTI:KMU-HE
    D.3.9.3Other descriptive namePLATELETS, HUMAN BLOOD
    D.3.9.4EV Substance CodeSUB127875
    D.3.10 Strength
    D.3.10.1Concentration unit µl microlitre(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150.000 to 350000
    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
    Venous ulcers in lower limbs
    Úlceras venosas en miembros inferiores
    E.1.1.1Medical condition in easily understood language
    Venous ulcers in legs
    Úlceras venosas en piernas
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10045373
    E.1.2Term Ulcers of extremities
    E.1.2System Organ Class 100000004858
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10024946
    E.1.2Term Lower extremities ulcers of
    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 verify the effectiveness of topical treatment with platelet-rich plasma in the healing of chronic lower limb venous ulcers.
    Comprobar la efectividad del tratamiento tópico con plasma rico en plaquetas en la cicatrización de úlceras crónicas venosas de miembros inferiores.
    E.2.2Secondary objectives of the trial
    - Localized pain in the ulcer decreases
    - Improvement in the physical affection as a result of the disease.
    - Improvement in the mental affectation as a result of the disease.
    - Adverse side effects incidence.
    - Disminución del dolor localizado en la úlcera.
    - Mejoría de la afectación física como consecuencia de la enfermedad.
    - Mejoría de la afectación mental como consecuencia de la enfermedad.
    - Incidencia de aparición de efectos secundarios adversos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age> 18 years.
    2. Ambulation without assistance by other people or by orthoses to perform daily activities.
    3. Ulcer below the knee, with venous etiology, which does not present clinical improvement or reduction of the area after 6 weeks of cures in our center.
    4. Pedal / tibial posterior pulse present or heel-arm index (ITB)> 0.8.
    5. Be able to provide informed consent prior to randomization and agree to comply with all procedures included in this protocol, including the follow-up phase.
    1. Edad > 18 años.
    2. Deambulación sin asistencia por otras personas o por ortesis para realizar actividades diarias.
    3. Úlcera por debajo de la rodilla, de etiología venosa, que no presente mejoría clínica ni reducción del área después de 6 semanas de curas en nuestro centro.
    4. Pulso pedio/tibial posterior presente o índice talón-brazo (ITB)>0,8.
    5. Ser capaz de proporcionar un consentimiento informado antes de la aleatorización y estar de acuerdo en cumplir todos los procedimientos incluidos en este protocolo, incluida la fase de seguimiento.
    E.4Principal exclusion criteria
    1. Ischemic aetiology's ulcers.
    2. Ulcers of more than 6 weeks of evolution but with tendency to cicatrization (by photographic comparison with the previous week).
    3. Patients of childbearing age with a positive pregnancy test on the day of screening.
    4. Female patients who are breastfeeding
    5. Male and female patients should agree to use highly effective contraceptive methods from the time of signing informed consent and up to at least 7 days after the completion of the study.
    1. Úlceras de etiología isquémica.
    2. Úlceras de más de 6 semanas de evolución pero con tendencia a la cicatrización (por comparación fotográfica con la semana anterior).
    3. Pacientes mujeres en edad fértil con una prueba de embarazo positiva el día del screening.
    4. Pacientes mujeres que se encuentre en período de lactancia
    5. Los pacientes hombres y mujeres deben aceptar usar métodos anticonceptivos altamente eficaces desde el momento de la firma del consentimiento informado y hasta al menos 7 días posteriores a la finalización del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Ulcer area: Weekly photographs will be taken with centimetric reference. Subsequently, the area will be calculated by a computer program (Acrobat®) by a blind investigator who does not know which group belongs to the ulcer
    Área de la úlcera: Se realizarán fotografías semanales con referencia centimetrada. Posteriormente se procederá al cálculo del área con programa informático (Acrobat®) por parte de un investigador ciego que desconoce a qué grupo pertenece la úlcera
    E.5.1.1Timepoint(s) of evaluation of this end point
    From day 0 (start of the trial) to week 52.
    Desde el día 0 (inicio del estudio) hasta la semana 52.
    E.5.2Secondary end point(s)
    • Pain: Measured using the WHO Visual Analog Scale.
    • Physical and mental component: It will be calculated using the standardized SF-12 quality of life questionnaire.
    • Adverse Events (AA): Any sign, symptom or undesirable clinical condition that occurs after the start of treatment is considered to be AA. Information about all AAs, whether they are voluntarily communicated by the patient, discovered by the investigator or detected on the physical examination will be recorded in an open general questionnaire.
    - Dolor: Se medirá utilizando la Escala Visual Analógica de la OMS.
    - Componente físico y mental: Se refiere al estado físico y mental del paciente en el momento evaluado y como consecuencia y en relación con la enfermedad investigada. Se calculará utilizando el cuestionario estandarizado de calidad de vida SF-12.
    - Acontecimientos adversos (AA): Se considerará AA cualquier signo, síntoma o estado clínico indeseable que tenga lugar después del inicio de la aplicación del tratamiento. La información sobre todos los AA, tanto si son comunicados voluntariamente por el paciente, descubiertos por el investigador o detectado en la examinación física será registrada en un cuestionario general abierto.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From day 0 (start of the trial) to week 52
    Desde el día 0 (inicio del estudio) hasta la semana 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    Última visita del último paciente
    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 months
    E.8.9.1In the Member State concerned days
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state50
    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)
    Safety Follow up visit
    Visitas de seguimiento de seguridad
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-25
    P. End of Trial
    P.End of Trial StatusOngoing
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