Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-004870-78
    Sponsor's Protocol Code Number:202100625
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-04
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-004870-78
    A.3Full title of the trial
    Detecting mitochondrial oxygen tension (mitoPO2) as a measure of local tissue oxygenation in patients with various stages of PAD with the Cellular Oxygen Metabolism (COMET) measurement system of Photonics Healthcare B.V. - A pilot study
    Detectie van mitochondriale zuurstofspanning (mitoPO2) als maat voor lokale weefseloxygenatie bij patiënten met verschillende stadia van PAD met het meetsysteem Cellular Oxygen Metabolism (COMET) van Photonics Healthcare B.V. - Een pilotstudie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Measuring oxygen in skin of patients with peripheral arterial disease with the COMET measurement system
    Zuurstof meten in de huid van patiënten met perifeer arterieel vaatlijden met het COMET-meetsysteem
    A.3.2Name or abbreviated title of the trial where available
    COMPASION
    COMPASION
    A.4.1Sponsor's protocol code number202100625
    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 SponsorUniversity Medical Centre Groningen
    B.1.3.4CountryNetherlands
    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 supportUniversity Medical Centre Groningen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Centre Groningen
    B.5.2Functional name of contact pointAbdallah Kaylani
    B.5.3 Address:
    B.5.3.1Street AddressZaagmuldersweg 1-43
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713LA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31687827217
    B.5.6E-maila.h.a.zaid.al-kaylani@umcg.nl
    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 Alacare
    D.2.1.1.2Name of the Marketing Authorisation holderphotonamic GmbH & Co. KG (Theaterstrasse 6, D-22880 Wedel, Germany)
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAlacare
    D.3.4Pharmaceutical form Cutaneous patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.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
    Peripheral Arterial disease
    Perifere arteriële ziekte
    E.1.1.1Medical condition in easily understood language
    Patients who have blockages in the blood supply of one or both of their legs.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine the feasibility and safety of mitochondrial oxygenation measurements with the COMET device and Alacare patch in patients with severe claudication (Rutherford class 4-6).
    E.2.2Secondary objectives of the trial
    The secondary objective(s) are:
    • To determine the optimal measurement location for the measurement of mitochondrial oxygen consumption with the best signal quality.
    • To determine the influence of application time for the Alacare patch on the signal quality.
    • To correlate the COMET device measurements to TcPO2 and ankle brachial index (ABI), and
    • To determine if signal quality drops after measuring in the place of the same Alacare patch spot.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 55 years and older.
    - Written informed consent.
    - Claudication, Rutherford class 4-6.
    E.4Principal exclusion criteria
    - Insufficient knowledge of the Dutch language, illiteracy, or language barrier.
    - Lower leg fracture within the past 12 months.
    - (Partial) amputation of one of the feet and/or legs.
    - Pregnant or breastfeeding.
    - Severe peripheral oedema and/or skin defects.
    - Severe cardiac-pulmonary failure.
    - Active cellulitis-erysipelas of the legs or other dermatological diseases.
    - Known hypersensitivity to the active substance or any of the following excepients: plasters: acrylic pressure sensitive adhesive (poly[(2-ethylhexyl)acrylate-co-methylacrylate-co-acrylic acid-co-glycidylmethacrylate]), backing film: pigmented polyethylene aluminium vapor coated polyester, and release liner (polyethylene terephthalate film) which is removed prior to application.
    - Known diagnosis of porphyria.
    - Known photodermatoses of varying pathology and frequency, e.g. metabolic disorders such as aminoaciduria, idiopathic or immunological disorders such as polymorphic light reaction, genetic disorders such as xeroderma pigmentosum, and diseases precipitated or aggravated by exposure to sun light such as lupus erythematoides or phemphigus erythematoides.
    - Diabetes.

    There will be no exclusion based on skin colour. Previous studies have confirmed that the device works with all skin colours and is not dependent on it.
    Patients will be asked if they have any known hypersensitivity.
    Photodermatosis has a clear profile. We will check patients’ medical history and will ask all subjects explicitly.
    Patients with PAD have more comorbidities, and often suffer from diabetes, cardiac and pulmonary diseases. A major complication of CLTI in combination with diabetes are non-healing ulcers of the lower extremity.
    E.5 End points
    E.5.1Primary end point(s)
    The main endpoint of this pilot study is the occurrence of itching, irritation/pain, or wounds at the site of the patch, and the feasibility of COMET measurements to determine tissue perfusion in the lower extremity in patients with moderate to severe claudication (Rutherford class 4-6) assessed by display of the measurements on the COMET monitor with sufficient signal quality. The verbal rating scale (VRS)31 will be used to assess itching. It is a 5-point Likert scale in which patients are asked to categorize their pruritus (0= “no itch,” 1= “weak itch,” 2= “moderate itch,” 3= “severe itch”, 4= ”very severe itch”). Irritation, pain, and wounds will be assessed visually and via standardised questionnaires.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients' safety will be monitored from the second they apply the Alacare until they leave the hospital.
    E.5.2Secondary end point(s)
    • Standardized and optimal measurement protocol in terms of location and time in patients with moderate to severe claudication (Rutherford class 4-6) through comparing signal quality at different locations and time points
    • COMET measurements in correlation with tcPO2 and ABI.
    • Difference in signal quality for the same location under the same Alacare patch at two measurement sessions.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the last measurement from the last patient has been concluded.
    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 No
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Pilot study
    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
    This use of the cream with the COMET device will be compared against ABI and TcPO2
    E.8.2.4Number of treatment arms in the trial1
    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
    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 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state20
    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.
    Geen.
    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 Decision2021-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-15
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA