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    Summary
    EudraCT Number:2009-011755-47
    Sponsor's Protocol Code Number:2007-001
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-04-28
    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 ConcernedGermany - PEI
    A.2EudraCT number2009-011755-47
    A.3Full title of the trial
    A feasibility study to evaluate the effect of Vivostat® Platelet Rich Fibrin (PRF®) in the treatment of diabetic foot ulcers
    A.3.2Name or abbreviated title of the trial where available
    PRF Diabetic Foot Study
    A.4.1Sponsor's protocol code number2007-001
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVivostat A/S
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Vivostat PRF
    D.2.1.1.2Name of the Marketing Authorisation holderVivostat A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameVivostat PRF
    D.3.2Product code NA
    D.3.4Pharmaceutical form Cutaneous spray, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeThe PRF® System is approved in the EU in 2003 as a medical device used for automated preparation and application of autologous platelet rich fibrin gel from whole blood.
    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
    - Diabetic foot ulcers Texas Grade I placed at or below the anchle
    -Non-ischaemic, non-infected ulcers
    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 purpose of this pilot study is to evaluate the healing effect of Vivostat® PRF® treatment of diabetic non-ischemic foot ulcers, to identify responders and to enable sample size calculation for a subsequent pivotal trial.

    Primary effect parameter:
    Proportion of completely healed ulcers after 12 weeks (defined as 100 % epithelialisation)
    E.2.2Secondary objectives of the trial
    Secondary effect parameters:

    - Time to complete healing
    - Percentage of patients with a 50% reduction of wound area after 4 weeks and 8 weeks
    - Granulation rate (the area covered with new granulation tissue)
    - Number of infections
    - The extend of maceration
    - Treatment time
    - Time used for kit preparation and blood donation at each treatment
    - Time used for application of PRF at each treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age: >18 years
    2. Type I or Type II Diabetes Mellitus
    3. Ulcer(s) at or below the ankle which have been present for at least 4 weeks, and have received best practice care
    4. Ulcer area between 0,5 and 16 cm2 after sharp debridement
    5. If there is more than one ulcer the investigator shall choose one index ulcer to be treated (typically the largest one). The other ulcers will receive standard care and are not to be included in the study. A maximum of 2 ulcers is allowed at the foot investi-gated
    6. Ulcer type: University of Texas grade IA.
    7. Evidence of adequate arterial perfusion: Toe pressure reading of ≥ 30 mmHg or if toe is missing, transcutaneous oxygen (TcPO2) of ≥ 30mmHg on the foot.
    8. Patient foot is appropriately off loaded (contact cast, pneumatic walking cast)
    9. Orthopaedic assessment has been completed to rule out a mechanical source of ulcera-tion
    10. Relative wound area reduction less than 50% from week –3 to week 0 (pre-screening period)
    11. Signed informed consent
    E.4Principal exclusion criteria
    1. Clear indication for surgery (vascular reconstruction or skin transplant)
    2. Ulcer with exposed bone or tendon
    3. Bone involvement (probe to bone or x-ray)
    4. Patients with 3 ulcers or more on at the foot investigated
    5. Osteomyelitis
    6. Clinical signs of infections in the ulcer studied
    7. Patients with Necrosis in the ulcer that cannot be removed by debridement at Week 0
    8. Patients with known Methicillin-resistant Staphylococcus aureus (MRSA) in the specific ulcer treated in the study
    9. Malnutrition. Albumin < 2,5g/dl
    10. Ulcers resulting from electrical, chemical, radiation burns
    11. HbA1c > 12%
    12. Male : Hb < 8 g/dl Female : Hb < 7 g/dl
    13. Platelet count <140 *109/l
    14. Pregnancy and fertile women not practising sufficient birth control
    15. Fertile women with a positive pregnancy test week 0
    16. Lactating women
    17. Patients on haemodialysis
    18. Limb ischemia requiring re-vascularisation or impending amputation
    19. History of peripheral vascular repair within 4 weeks prior to randomization
    20. Bleeding disorders, haemophilia, sickle cell disease, thrombocytopenia, and leukaemia or blood dyscrasias
    21. Current treatment for malignancy or neoplastic disease or collagen scular disease
    22. Patient has a highly communicable disease or diseases that may limit follow
    23. Patients with immuno-compromised conditions, hepatitis, active tuberculosis
    24. Patient has inadequate venous access to draw blood
    25. History of alcohol or drug abuse within the last year prior to randomization
    26. Patient known to have psychological, developmental, physical, emotional or social dis-order or other ailments that may interfere with the study requirements
    27. Patients enrolled in an other clinical trial for wound treatment within 30 days prior to enrolment
    28. Non-compliance in the screening period
    29. Patients who have received growth factor therapy e.g. becaplermin within 7 days prior to enrolment
    30. Relative wound area reduction greater than 50% from Week-3 to Week 0 (Run-in)
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of completely healed ulcers after 12 weeks (defined as 100 % epithelialisation)
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Identify responders
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.1.7.1Other trial design description
    Feasibility study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 Information not present in EudraCT
    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
    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 days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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 Decision2009-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-17
    P. End of Trial
    P.End of Trial StatusOngoing
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