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    Summary
    EudraCT Number:2012-002247-20
    Sponsor's Protocol Code Number:UIAPB-PRP-2012
    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:2012-07-19
    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 number2012-002247-20
    A.3Full title of the trial
    Feasibility, potential efficacy and safety of autologous platelet-rich plasma in the treatment of vascular venous ulcers in Primary Care (phase I and II pilot study)
    Factibilidad, eficacia potencial y seguridad del Plasma Rico en Plaquetas autólogo en el tratamiento de úlceras vasculares en Atención Primaria: Estudio piloto fase I-II
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Check if fatible and can be effective if the use of PRP in vascular ulcers in the field of primary care
    Comprobar si es factible y si puede ser efectivo el uso de PRP en ulceras vasculares en el ambito de atencion 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-PRP-2012
    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.4.1Name of organisation providing supportDepartamento de Sanidad Gobierno Vasco
    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 ulcers, aged 40 to 80 years old, registered in five different health centres will be studied.
    Pacientes con úlceras vasculares venosas, entre 40-80 años de edad y adscritos a cinco centros de salud de la Comarca Ezkerraldea-Enkarterri de Osakidetza, Servicio Vasco de Salud.Please enter information in other language that is applicable
    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 14.1
    E.1.2Level HLT
    E.1.2Classification code 10040796
    E.1.2Term Skin and subcutaneous tissue ulcerations
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the feasibility of the treatment with autologous platelet-rich plasma (PRP), estimating the percentage of the patient who need one heal per week during the two months of treatment.
    To assess the potential efficacy of the treatment with autologous platelet-rich plasma (PRP), estimating the reduction of the ulcer. The area of the wound is compared between baseline, after a month and two months of treatment, measuring the area in cm2 by image processing of photographs of the ulcer using ImageJ software.
    Evaluar la factibilidad de la utilización del PRP autólogo en el tratamiento de úlceras venosas, estimando el porcentaje de personas que precisan una sola cura semanal durante los dos meses que dure el tratamiento.
    ? Evaluar la eficacia potencial atribuible al PRP autólogo estimando la reducción del área de la úlcera mediante la valoración de fotografías seriadas, en el momento basal, al mes de tratamiento y a los dos meses desde el inicio del tratamiento, comparándolo con lo observado en el grupo control.
    E.2.2Secondary objectives of the trial
    To assess the safety of autologous PRP for the treatment of venous ulcers in patients with CEAP stage 6 chronic venous insufficiency, considering reduction in pain, the percentage of infected ulcers and wound edge, in the two groups and these variables being compared between the groups.
    To assessed using the CIVIQ, which considers four dimensions (physical, psychological, social and pain) between baseline, after a month 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 resident in Barakaldo, who are seen in treatment rooms at the Zaballa outpatient clinic or one of the following health centres: Zaballa, La Paz, Urban, or San Vicente, in the Ezkerraldea-Enkarterri Health Region of the Basque Health Service - Osakidetza.
    ? Men or women of 40 to 80 years of age
    ? Patients with stage C6 chronic venous insufficiency according to the CEAP classification
    ? Patients with vascular ulcers which have not responded to conventional treatment in 2 to 6 months
    ? Patients with normal number of platelet and red corpuscles and normal range of hematocrit.
    ? An ulcer of 3-5 cm in diameter
    ? An ABI of greater than or equal to 0.8 or less than or equal to 1.5.
    ? Independent patients or with sufficient family support
    ? Patients have given written informed consent (Appendices 03 and 04)
    ? Pacientes de Barakaldo, que acudan a sala de curas de los centros de salud de San Vicente, Zaballa, La Paz, Desierto y el Consultorio de Zaballa, 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 80 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 de 2 a 6 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.
    ? Ulceras cuyo tamaño se encuentre entre 3 y 5 cm de diámetro.
    ? 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 (anexo 3 y 4).
    E.4Principal exclusion criteria
    ? Chronic treatment with immunosuppressive or retroviral drugs.
    ? Coagulopathies.
    ? Patients with chronic infectious diseases.
    ? Patients in treatment with radiotherapy or chemotherapy.
    ? History of malignancy.
    ? Patients with more than two active ulcers.
    ? Pregnancy.
    ? Patients with current infection or febrile syndrome at the beginning of treatment.
    ? Patients with AAI (Ankle Arm Index) less than 0.8 and greater than 1.5
    ? Pacientes en tratamiento crónico con inmunosupresores o retrovirales.
    ? Coagulopatías.
    ? Pacientes con enfermedades infecciosas crónicas.
    ? Pacientes en tratamiento con radioterapia o quimioterapia.
    ? Pacientes con historia de neoplasia.
    ? Pacientes con más de dos úlceras activas.
    ? Embarazadas.
    ? Pacientes con infección activa o síndrome febril al inicio del estudio.
    ? Pacientes con ITB menor de 0.8 o mayor de 1.5.
    E.5 End points
    E.5.1Primary end point(s)
    % OF PATIENTS WITH ONLY ONE CORE PER WEEK
    CIVIQ SCORE
    ULCER AREA
    % DE PACIENTES CON UNA SOLA CURA SEMANAL
    REDUCCIÓN DEL TAMAÑO ULCERAL
    INDICE CIVIQ
    AREA ÚLCERA
    E.5.1.1Timepoint(s) of evaluation of this end point
    Basal, 5th and 9th week
    Basal, 5ª y 9ª semana
    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
    E.5.2.1Timepoint(s) of evaluation of this end point
    Basal
    Basal
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    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 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
    The last test will be held after 9 weeks of the inclusion of the last patient
    La ultima prueba se realizara despues de 9 semanas de la inclusion del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state40
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-24
    P. End of Trial
    P.End of Trial StatusOngoing
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