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    Summary
    EudraCT Number:2018-003596-36
    Sponsor's Protocol Code Number:RAPID-1DFU[2018/08]
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-06-27
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-003596-36
    A.3Full title of the trial
    A single centre, open label Randomised Controlled Trial of the RAPID™* PRP (Platelet Rich Plasma) Haematogel Wound Care Treatment in addition to Usual and Customary Care, (UCC); compared to Usual and Customary Care (UCC) alone, in the management of adult patients with chronic Diabetic Foot Ulcers.

    RAPID™* [Restorative Autologous Platelet biotherapies for treatment of Injuries & Delayed wound healing] Biodynamic Platelet Rich Plasma [PRP] Haematogel
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RAPID-1 Diabetic Foot Ulcer Randomised Controlled Study
    A.3.2Name or abbreviated title of the trial where available
    RAPID-1 Diabetic Foot Ulcer Study [Version 2.0]
    A.4.1Sponsor's protocol code numberRAPID-1DFU[2018/08]
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN55474813
    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 SponsorBiotherapy Services Ltd.
    B.1.3.4CountryUnited Kingdom
    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 organisationBiotherapy Services Ltd.
    B.5.2Functional name of contact pointManaging Director
    B.5.3 Address:
    B.5.3.1Street Address59-60 Gainsborough House
    B.5.3.2Town/ cityWindsor
    B.5.3.3Post codeSL4 1TX
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number +44 (0) 207 788 7828
    B.5.6E-mailjanet.hadfield@biotherapyservices.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 No
    D.2.1.1.1Trade name Angel Concentrated Blood Processing System and kits
    D.2.1.1.2Name of the Marketing Authorisation holderArthrex and Biotherapy Services
    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 nameRAPID Biodynamic Haematogel
    D.3.4Pharmaceutical form Blood fraction modifier
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPLocal use (Noncurrent)
    Soft tissue use (Noncurrent)
    Cutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNL-ascorbic acid
    D.3.9.1CAS number 8-55-9
    D.3.9.2Current sponsor codeNDC 67457-118-50
    D.3.9.3Other descriptive nameVitamin C for Injection
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEthyl Alcohol, USP/NF
    D.3.9.1CAS number 64-17-5
    D.3.9.2Current sponsor codeActivAT Autologous Thrombin Processing Kit Cat No. 966150000
    D.3.9.3Other descriptive nameActivAT Autologous Thrombin Kit
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40 to 50
    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) 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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The treatment of chronic diabetic foot ulcers of longer than 12weeks duration.
    E.1.1.1Medical condition in easily understood language
    Diabetic foot ulcers are a significant complication of Diabetes [Type 1 and Type 2], affecting 1:4 diabetics.
    E.1.1.2Therapeutic area Body processes [G] - Cell Physiological Phenomena [G04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10016980
    E.1.2Term Foot ulcer
    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


    The primary objective of this pilot study, is to determine safety and efficacy of the addition of the RAPID PRP Gel treatment to usual and customary care, in complete wound healing of chronic diabetic foot ulcers, within 12 weeks
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    1. To investigate the correlation between the defined treatment modalities and wound infection.
    2. To investigate the correlation between the defined treatment modalities and number of patients proceeding to amputations.
    3. To investigate the correlation between the defined treatment modalities and pain scores.
    4. To investigate the health-related quality of life and patient satisfaction.
    5. Define the cost of treatment between the two treatment arms.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be eligible for this study if they meet the following inclusion criteria:
    1. Ability to give written informed consent
    2. Male or female with confirmed type 1 or type 2 diabetes.
    3. Age 18-90 years.
    4. Diabetic foot ulcer (DFU) measuring more than 0.5cm x 0.5cm and lesser than 10cm x 10cm, present for more than 12 weeks.
    5. Only one ulcer present on the affected limb.
    6. Patient understands and is willing to participate and can comply with the follow-up regime.
    7. Patient understands and is willing to participate in full UCC, including recommended off-loading strategy
    E.4Principal exclusion criteria
    Patient will be consdiered inelgible if they have any of the following:

    1. Wound with active infection which simple debridement cannot eradicate; any post-debridement remaining underlying osteomyelitis
    2. Patients with underlying vascular insufficiency (If ABPI<0.9 or ABPI>1.3, duplex or other arterial imaging will be required to demonstrate in-line flow into the foot).
    3. Uncontrolled Diabetes Mellitus, as measured by an HbA1c > 10%. (86mmol/mol)
    4. Hb<10.5g/dl
    5. One or more of the following medical comorbidities - hepatic, hematologic, active auto-immune or immune diseases.
    6. Patient with known or suspected current malignancy.
    7. Patient not fit for surgery (ASA classification > 4)
    8. Poor venous access.
    9. Critical thrombocytopenia
    10. Septicemia
    11. Platelet count of<100/ul
    12. Serum albumin of <2.5g/dL
    13. Pregnancy
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the proportion of wounds healed at 12weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Wounds will be measured and photographed from the commencement of treatment, on a weekly basis until 100% wound healing is achieved.

    The cut off point of treatment using the RAPID Biodynamic PRP Haematogel is if <50% wound healing is achieved by week 6.
    E.5.2Secondary end point(s)
    The Secondary endpoints include:

    ¬ Incidence of amputations.
    ¬ proportion of completely healed DFUs (University of Texas DFU Classifications).
    ¬ change in the Wound QoL and EQ-5D-5L Questionnaire mean scores.
    ¬ To investigate the correlation between the defined treatment modalities and wound microbiology and antibiotic usage

    Exploratory endpoints/outcomes
    ¬ To investigate the correlation between the defined treatment modalities and wound complications.
    ¬ Investigate the overall cost effectiveness of the RAPID PRP gel wound dressing treatments in comparison to standard dressing regimes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Interim Time points for evaluation at 12weeks.
    Final evaluation time point is the scheduled 6month follow up appointment.
    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) Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Usual and Customary Care and Aquacel as the primary dressing.
    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.8.5.1Number of sites anticipated in the EEA1
    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
    RAPID-1 DFU Study will end when the last patient has had their final study visit for review of patient and wound closure (scheduled at 12 weeks post randomisation plus 6months - visit 14).
    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 months5
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    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: 32
    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 state66
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 66
    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)
    This research should provide proof of safety and efficacy of the study treatment.
    The medical devices used to produce the RAPID Biodynamic Haematogel Dressing are all CE marked devices, with the exception of the ActivAT autologous thrombin device; which is currently undergoing re-certification. It is anticipated that the safety and efficacy data will support this re-certification.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-30
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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