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    Summary
    EudraCT Number:2020-003326-23
    Sponsor's Protocol Code Number:DT-DP-DFU-CR-05
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-08-06
    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 ConcernedLatvia - SAM
    A.2EudraCT number2020-003326-23
    A.3Full title of the trial
    A Prospective, Randomized, Double-Blind, Vehicle-Controlled Study To Evaluate The Safety and Efficacy of Diperoxochloric Acid (DPOCl, DermaPro®) In Patients With Non-Healing Diabetic Foot Ulcers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the efficacy of a new wound healing solution (DermaPro®) in patients with diabetic foot ulcers
    A.3.2Name or abbreviated title of the trial where available
    Phase III Study of DermaPro® for the Treatment of Diabetic Foot Ulcer
    A.4.1Sponsor's protocol code numberDT-DP-DFU-CR-05
    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 SponsorDermaTools Biotech GmbH
    B.1.3.4CountryGermany
    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 supportDermaTools Biotech GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDermaTools Biotech GmbH
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressCarl Zeiss Str 35/IV
    B.5.3.2Town/ cityRödermark
    B.5.3.3Post code63322
    B.5.3.4CountryGermany
    B.5.4Telephone number004961519515812
    B.5.6E-maildfu-05@dermatools.de
    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.2.5The 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 nameDermaPro®
    D.3.2Product code DPOCl
    D.3.4Pharmaceutical form Concentrate and solvent for 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 INNClorate(2-)tetraoxo[µperoxy-k01-k02)]di-,sodium (1:2)
    D.3.9.1CAS number 2113603-76-0
    D.3.9.2Current sponsor codeDPOCl
    D.3.9.3Other descriptive nameDIPEROXOCHLORIC ACID
    D.3.9.4EV Substance CodeSUB167232
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/l millimole(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.0
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate and solvent for cutaneous solution
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    3. Diabetic foot ulcer treated unsuccessfully for at least 4 weeks with mean diameter between 1.5 and 4 cm after débridement
    E.1.1.1Medical condition in easily understood language
    Diabetic foot ulcers treated for at least 4 weeks unsuccessfully
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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
    Primary objective is to confirm the superiority of 1.2 mM DPOCl compared to vehicle solution in achieving complete wound closure in the tested sample of patients with Diabetic Foot Ulcer
    E.2.2Secondary objectives of the trial
    Secondary efficacy objective(s)
    • To describe efficacy of DPOCl 1.2 mM solution
    • To obtain data on the occurrence of wound infections
    • To obtain data on the improvement of symptoms, signs and QoL

    Safety objective(s)
    • To obtain safety and tolerability data for treatment with DPOCl 1.2 mM solution
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The patient must have given written informed consent.
    2. Age: ≥18 years, inclusive of the date of randomization.
    3. Diabetic foot ulcer with mean diameter between 1.5 and 4 cm after débridement (1.5 and 4 cm if debridement is not indicated), determined as longest length + longest width)/2
    • Wound shapes other than circular must have both a length and width of at least 1.5 cm.
    • Wound stage Wagner grade I or II, Armstrong stadium A or C (for Wagner-Armstrong-Classification see Appendix 1), treated unsuccessfully for at least 4weeks.
    • The duration of non-healing ulcer presence prior to study should be at least 4 weeks
    Should more than one eligible wound be present, only one will be selected by the investigator, not closer than 3 cm to adjacent ulcers (“target wound”).
    Note: Other wounds with impaired healing, e.g. decubitus ulcer, arterial and/or venous leg ulcer, Charcot's foot or malum perforans, may be present in the same patient but shall not be selected as targets for the present study.
    4. Type 1 or type 2 Diabetes Mellitus under metabolic control as confirmed by a glycosylated hemoglobin (HbA1c) ≤ 12% at screening. The laboratory results may not be older than 3 month at the date of randomization.
    5. Adequate perfusion of the lower leg on the affected side determined by either:
    • an ankle / brachial ratio of > 0.7
    • or systolic blood pressure of either > 50 mm Hg (big toe)
    • or > 70 mm Hg (dorsalis pedis)
    as determined by an appropriate method, according to local use, concerning the foot pulse to exclude patients who require a revascularization therapy; examination results should be not older than 3 months.
    6. Females of non-childbearing potential defined as being amenorrhoeic for longer than 2 years with an appropriate clinical profile or surgically sterile.
    • If of childbearing potential the patient must use an adequate birth control and must have a negative pregnancy test.
    E.4Principal exclusion criteria
    1. Clinical evidence of ulcer bed infection requiring treatment with topical or systemic antibiotics
    2. Suspicion of bone infection or osteomyelitis* affecting the area of target wound.
    3. An ulcer primarily ischemic in etiology
    Note: The ulcer is primarily ischemic in etiology as diagnosed by an ABI of ≤ 0.7 on the affected extremity or systolic pressure of ≤ 50 mmHg (great toe) or ≤ 70 mmHg (dorsalis pedis).
    4. Revascularisation of the affected leg done less than 3 months before randomization or planned revascularization procedure.
    5. Start or change of a new off-loading strategy (already existing off-loading device at the investigator´s discretion, is optimally applied and must be maintained).
    6. Clinically significant abnormal values in clinical chemistry except those typical for the underlying diseases mentioned in the inclusion criteria (for ranges see laboratory manuals of the laboratories of the participating sites/ countries). These exceptions are at the discretion of the Investigator and taken into account the tolerated ranges given in the table in Section 11.3.9.
    Note. Patients with a high blood glucose level are eligible, provided HbAc1 ≤ 12% at screening.
    7. Severe or uncontrolled heart disease (NYHA class III or IV, see Appendix 2).
    8. Diagnosis of renal failure or treatment with dialysis.
    9. Active severe hepatic disease, which might have an impact on wound healing.
    10. Concurrent illness or a condition that may interfere with wound healing other than those mentioned in the inclusion criteria (e. g. carcinoma, haematological disease, vasculitis, connective tissue disease, alcohol neuropathy).
    11. Previous radiation of the region of the target wound selected for the study.
    12. Exposure of any systemic immunosuppressive or cytostatic therapy or growth factors during the previous 30 days prior to the study, including the day Informed Consent is given.
    13. Severe psychiatric or neurological disorder.
    14. Incapability of giving informed consent.
    15. Co-worker, student, relative or spouse of the investigator.
    16. Previous participation in this present study.
    17. Participation in another experimental clinical study during the previous 3 months prior to entry into the present study.
    18. Current drug or alcohol abuse.
    19. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patients at risk because of participation in the trial, or may influence the result of the trial, or the patient’s ability to participate in the trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the rate of subjects achieving complete wound closure (CWC, responder).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weekly
    E.5.2Secondary end point(s)
    1. Time to complete wound closure for each treatment group.

    Determination of time point (date) at which CWC confirmed by the independent adjudicator was first observed for each patient by the investigator, if CWC

    2. Sustainability of wound closure for each treatment group compared to reference.

    3. Relative wound area reduction (percentage change between last visit (EOT) and baseline as compared to baseline), as measured by computerised wound area determination. The percent changes from baseline to each visit will also be evaluated.

    4. Wound area reduction (change between last visit (EOT) and baseline), as measured by computerised wound area determination. The changes from baseline to each visit will also be evaluated.

    5. Course of wound area reduction over time.

    6. Occurrence of wound infection

    7. Improvement of symptoms (e.g. itching, pain, wellbeing).

    Evaluation of symptoms improvement assessed by a Visual Analogue Scale (VAS).

    8. Improvement of symptoms and signs (e.g. prickling, heat sensation, cold sensation, numbness, furry feeling, smell, exudation).

    Measurement of symptoms improvement by a rating scale.

    9. Quality of Life
    A validated standardised QoL questionnaire, EQ-5d, will be used at base line and EoT visit.

    Exploratory end point: Proportion of patients requiring systemic antibiotic intervention.due to occurrence of wound infection
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weekly
    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 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) 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 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
    vehicle solution
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Georgia
    Russian Federation
    Austria
    Germany
    Latvia
    Lithuania
    Poland
    Greece
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial 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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 400
    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)
    Standard of care
    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 Decision2021-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-08
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