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    Summary
    EudraCT Number:2020-001365-36
    Sponsor's Protocol Code Number:2020-001365-36
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-09-29
    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 ConcernedSweden - MPA
    A.2EudraCT number2020-001365-36
    A.3Full title of the trial
    A randomized double-blind clinical trial comparing Hypochlorous Acid and Polyhexamethylene biguanide in treating diabetic foot ulcers
    En randomiserad dubbelblind klinisk prövning jämförande Hypoklorsyra med Polyhexametylen biguanid vid behandling av fotsår hos personer med diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cleaning infected foot ulcers in people with diabetes: compairing two different solutions, which is best?
    Rengöring av infekterade fotsår hos personer med diabetes: jämförande två olika lösningar, vilken är bäst?
    A.3.2Name or abbreviated title of the trial where available
    Dakin´s - Diabetes
    Dakins - Diabetes
    A.4.1Sponsor's protocol code number2020-001365-36
    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 SponsorNU-hospital Group/Västra Götalandsregionen
    B.1.3.4CountrySweden
    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 supportVGR NU-sjukvården
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportGöteborgs universitet
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNU-hospital Group
    B.5.2Functional name of contact pointMarcus Lind
    B.5.3 Address:
    B.5.3.1Street AddressLedningskansliet för NU-sjukvården
    B.5.3.2Town/ cityTrollhättan
    B.5.3.3Post codeSE 461 85
    B.5.3.4CountrySweden
    B.5.4Telephone number4610435 00 00
    B.5.6E-mailnusjukv.kansli@vgregion.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Dakin´s solution
    D.2.1.1.2Name of the Marketing Authorisation holderAPL
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameDakin´s Solution
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDakin´s solution
    D.3.9.1CAS number 7681-52-9
    D.3.9.3Other descriptive nameSODIUM HYPOCHLORITE
    D.3.9.4EV Substance CodeSUB15292MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    Infected foot ulcers in people with diabetes
    Infekterade fotsår hos personer med diabetes
    E.1.1.1Medical condition in easily understood language
    Infected foot ulcers in people with diabetes
    Infekterade fotsår hos personer med diabetes
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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
    Time to healing
    Tid till läkning
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial are to evaluate if treatment with HClO and PHMB in treating DFU differ with respect to:
    a. Proportion of DFU that heals within 12 weeks of treatment
    b. The size of the DFU´s surface area over 24 weeks of treatment
    c. The depth of the DFU over 24 weeks of treatment
    d. Use of antibiotics over 24 weeks of treatment
    e. Quality of life over 24 weeks of treatment using the EQ-5D questionnaire
    Det sekundära målet är att undersöka om användning av HClO och PHMB skiljer sig åt i avseende:
    a. Del av diabetesfotsåret som läker inom 12 veckors behandling
    b. Storleken på diabetesfotsårets yta under 24 veckors behandling
    c. Djupet på diabetesfotsåret under 24 veckors behandling
    d. Användning av antibiotika under 24 veckors behandling
    e. Livskvalité under 24 veckors behandling insamling med EQ-5D- enkät
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be included the subject must meet the following criteria:
    • Written and verbal informed consent given before trial-related activities
    • Diabetes type 1, type 2 or diabetes due to pancreatitis
    • Foot ulcer ≥ 10 days
    • Ulcer surface area ≥ 9 mm2
    • Age 18 years old or older
    • Skriftligt och muntligt samtycke före studie-relaterade händelser
    • Typ 1 diabetes, typ 2 diabetes eller diabetes pga pankreatit
    • Fotsår ≥ 10 dagar
    • Yta, fotsår ≥ 9 mm2
    • Ålder 18 år eller äldre
    E.4Principal exclusion criteria
    Under 18 years old, serious infection (temp <36 or >38, heartrate >90 beats/minute, resp rate >20/min, LPK >12X10ᶺ9), condition needing intensive care and dialysis, treatment with immunotherapy and/or corticosteroids ≥ 50 mg/day, event of myocardial infarction or stroke during the last 4 weeks, debut of atrial fibrillation or heart failure (ejection fraction <40 %) during the last 4 weeks
    Under 18 år, svår infektion (temp<36 eller >38, hjärtfrekvens >90 slag/min, andningsfrekvens >20/min, LPK>12x 10ᶺ9), i behov av intensivvård eller dialys, immunoterapi och/eller kortison ≥ 50 mg per dag samt hjärtinfarkt, stroke, förmaksflimmer eller hjärtsvikt de senaste fyra veckorna.
    E.5 End points
    E.5.1Primary end point(s)
    Difference in time to healing of DFU for patients randomized to hypochlorous acid (HClO) compared with those randomized to Polyhexamethylene biguanide (PHMB) from baseline (randomization) over a maximal follow-up of 24 weeks.
    Skillnad i tid för läkning av diabetesfotsår för patienter randomiserade till hypoklorsyra (HClO) i jämförelse med de som randomiserats till Polyhexametylen biguanid (PHMB) från baseline (randomisering) över en period på max 24 veckor.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The participants wil be treated until the ulcer has healed or at the most 24 weeks
    Deltagarna kommer att behandlas tills såret är läkt eller till och med 24 veckor
    E.5.2Secondary end point(s)
    a. Proportion healed DFUs in HClO group versus PHMB group at week 12
    b. The difference in the change of the surface area of the DFU for patients treated with HClO versus PHMB from baseline (randomization) over 24 weeks.
    c. The difference in the change of the depth of the DFU for patients treated with HClO versus PHMB from baseline (randomization) to week 24.
    d. Difference in the mean number of days of antibiotic treatment for patients treated with HClO versus PHMB from baseline (randomization) to week 24.
    e. Difference in the change of quality of life using the EQ5-D questionnaire for patients treated with HClO versus PHMB from baseline (randomization) to week 24.
    a. Andelen läkta sår i HClO-gruppen i jämförelsevis med PHMB-gruppen vid vecka 12
    b. Skillnaden i förändring av ytarean av DFU för patienter behandlade med HClO i jämförelse med PHMB från baseline (randomisering) över 24 veckor.
    c. Skillnaden i förändringen av djup av DFU för patienter behandlade med HClO i jämförelse med PHMB från baseline (randomisering) till vecka 24.
    d. Skillnaden i medeltal av antalet dagar med antibiotikabehandling för patienter behandlade med HClO i jämförelse med PHMB från baseline (randomisering) till vecka 24.
    e. Skillnad i förändring av livskvalité EQ5-D enkät som underlag för patienter behandlade med HClO i jämförelse med PHMB från baseline (randomisering) till vecka 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    Randomisering, week 12, when healed and week 24
    Vid randomisering, vecka 12, när läkt och vecka 24
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Level of antibiotic use.
    Nivå av användning av antibiotika.
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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
    Medicin teknisk produkt klass 3
    Medical device class III
    E.8.2.4Number of treatment arms in the trial2
    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 concerned16
    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 Yes
    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
    Sista besöket för sista deltagaren.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 152
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-09-29. Yes
    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 state202
    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)
    The treatment after the trial will be the ordinary treatment given at each site
    Behandlingen efter den kliniska studien kommer att vara den ordinarie behandlingen som ges på varje plats
    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 Decision2021-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-27
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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