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    Summary
    EudraCT Number:2018-000575-32
    Sponsor's Protocol Code Number:1
    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:2018-11-23
    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 number2018-000575-32
    A.3Full title of the trial
    Results of the injection of botulinum toxin vs platelet rich plasma for the treatment of plantar fasciitis
    Resultados de la infiltración de toxina botulínica vs plasma rico en plaquetas en el tratamiento de la fascitis plantar
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Results of the injection of botulinum toxin vs platelet rich plasma for the treatment of plantar fasciitis
    Resultados de la infiltración de toxina botulínica vs plasma rico en plaquetas en el tratamiento de la fascitis plantar
    A.4.1Sponsor's protocol code number1
    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 SponsorIsabel Maria Ruiz
    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 supportHospital Son Llátzer
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Son Llátzer
    B.5.2Functional name of contact pointSecretaría Traumatología
    B.5.3 Address:
    B.5.3.1Street AddressHospital Son Látzer, (Secretaría de Traumatología) Carretera de Manacor km4
    B.5.3.2Town/ cityPalma de Mallorca
    B.5.3.3Post code07198
    B.5.3.4CountrySpain
    B.5.6E-mailxavigas@gmail.com
    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 Yes
    D.2.1.1.1Trade name BOTOX
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameBOTOX
    D.3.4Pharmaceutical form Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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 No
    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.IMP: 2
    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 nameplatelet rich plasma
    D.3.2Product code PRP
    D.3.4Pharmaceutical form Blood fraction modifier
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Infiltration
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPRP
    D.3.9.3Other descriptive namePLATELETS
    D.3.9.4EV Substance CodeSUB25592
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1000000
    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
    Plantar fasciitis
    Fascitis plantar
    E.1.1.1Medical condition in easily understood language
    Heel pain caused by persistent inflammation at the plantar fascia (an anatomic structure found in the heel)
    Dolor plantar causado por inflamación persistente en la fascia plantar (una estructura anatómica que se encuentra en la planta del pie)
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10035155
    E.1.2Term Plantar fasciitis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective 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 compare the effectiveness of botulinum toxin type A vs platelet rich plasma injections to treat plantar fasciitis, and with a control group without injections.
    Comparar la eficacia (alivio del dolor y mejora de la función) de las inyecciones de Toxina Botulínica A (BTX-A) con las inyecciones de Plasma Rico en Plaquetas (PRP) para el tratamiento de la fascitis plantar crónica y con un grupo control no sometido a infiltraciones
    E.2.2Secondary objectives of the trial
    To evaluate changes in fascia plantar thickness by ultrasonography.
    To do an analysis cost-effectiveness
    Valorar los cambios ecográficos de la fascia plantar tras las inyecciones de ambas sustancias.
    Realizar un análisis comparativo coste-efectividad de ambos tratamientos intervencionistas entre sí y con el grupo control.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Clinic diagnosis of plantar fasciitis
    - Failure of conservative treatment for 3 months
    - Informed consent understood and signed
    - Patients aged 18 or more
    - No previous injections or surgery to treat plantar fasciitis
    - Diagnóstico clínico de Fascitis Plantar
    - Persistencia de síntomas tras un mínimo de 3 meses de tratamiento conservador
    - Entiende y firma consentimiento informado para participar en el estudio
    - Mayor de 18 años
    - No inyecciones previas ni intervenciones quirúrgicas sobre la fascia plantar
    E.4Principal exclusion criteria
    - Inflammatory arthropathies (Rheumatoid arthritis, psoriasis, Reiter’s síndrome, ankylosing spondylitis)
    - Neurologic diseases
    - Mental retardation or psychiatric abnormalities which can lead misunderstanding of the informed consent
    - Cutaneous infection
    - History of infection in the previous 3 months at the application site
    - Patients who do not complete the follow-up appointments
    - Previous treatements for plantar fasciitis including injections, surgery or extracorporeal shock wave
    - Syntomps during less than 3 months
    - Surgery in the lower limb within the last 6 months
    - Pregancy and lactancy
    - Oral anticoagulants
    - Artropatías inflamatorias (artritis reumatoide, psoriasis, Sd. De Reiter, espondilitis anquilopoyética)
    - Enfermedades neurológicas
    - Retraso mental o enfermedades psiquiátricas que pueda influir en la comprensión o cumplimiento del protocolo del estudio
    - Infección cutánea
    - Historia de infección en el lugar de aplicación en los 3 meses previos
    - No acudir a las visitas durante el seguimiento
    - Haber recibido ondas de choque, otras inyecciones previas o cirugía en la fascia plantar
    - Menos de 3 meses de evolución de los síntomas
    - Cirugía en miembros inferiores en los últimos 6 meses
    - Embarazo y lactancia
    - Toma de anticoagulantes orales
    E.5 End points
    E.5.1Primary end point(s)
    • Pain (VAS)
    • Function (AOFAS, ROM, Silverskiold test)
    • Quality of life (SF-36)
    - Dolor (VAS)
    - Función (AOFAS, BA, Silverskiold test)
    - Calidad de vida (SF-36)
    E.5.1.1Timepoint(s) of evaluation of this end point
    • 1st visit
    • 3 weeks
    • 3 months
    • 6 months
    • 1 year
    • 1ª visita
    • 3 semanas
    • 3 meses
    • 6 meses
    • 1 año
    E.5.2Secondary end point(s)
    • Inflammation (Plantar fascia thickness measured by US)
    - Cost-effectiveness analysis of both treatments and versus no intervention
    - Inflamación (grosor ecográfico fascia plantar)
    - Análisis coste efectividad de ambos tratamientos versus no intervención
    E.5.2.1Timepoint(s) of evaluation of this end point
    • 1st visit
    • 3 weeks
    • 3 months
    • 6 months
    • 1 year
    • 1ª visita
    • 3 semanas
    • 3 meses
    • 6 meses
    • 1 año
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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 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
    no inyección, medidas de tratamiento conservador solo
    no injection, conservative measures only
    E.8.2.4Number of treatment arms in the trial3
    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 end of the trial it would be the last visit of the last subject undergoing the trial
    El estudio finalizará con la última visita de último sujeto que participe en el mismo
    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: 51
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state51
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 51
    F.4.2.2In the whole clinical trial 51
    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)
    None
    Ninguno
    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 Decision2018-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-28
    P. End of Trial
    P.End of Trial StatusOngoing
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