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    Summary
    EudraCT Number:2012-005841-19
    Sponsor's Protocol Code Number:DT-DP-D3
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-10
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2012-005841-19
    A.3Full title of the trial
    A Multicentric, Double Blind, randomised, Comparative Phase III Study of the Efficacy of the new Wound Healing Solution Diperoxochloric acid (DPOCL, DermaPro®) compared to isotonic Sodium Chloride Solution 0.9% in Patients with 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
    DermaPro® versus isotonic sodium chloride solution in patients with diabetic foot ulcers
    A.4.1Sponsor's protocol code numberDT-DP-D3
    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 pointDr. Dirk Kaiser
    B.5.3 Address:
    B.5.3.1Street AddressEisenacher Straße 4
    B.5.3.2Town/ cityRödermark
    B.5.3.3Post code63322
    B.5.3.4CountryGermany
    B.5.4Telephone number00496151951 5812
    B.5.5Fax number00496151951 5813
    B.5.6E-mailstudie@cytotools.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 for cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDiperoxochloric acid
    D.3.9.3Other descriptive nameDiperoxochloric acid
    D.3.10 Strength
    D.3.10.1Concentration unit mmol millimole(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.8
    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.IMP: 2
    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 Isotone Kochsalz-Lösung 0,9 % Braun
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Melsungen AG
    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.3.4Pharmaceutical form Irrigation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsodium chloride
    D.3.9.1CAS number 7647-14-5
    D.3.9.3Other descriptive nameSODIUM CHLORIDE SOLUTION 0.9%
    D.3.9.4EV Substance CodeSUB20079
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    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
    Diabetic foot ulcers with mean diameter between 1.5 and 5 cm after débridement (if indicated); wound stage Wagner grade I or II, Armstrong stadium A or C (for Wagner-Armstrong-Classification), treated for at least 4 weeks unsuccessfully
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10012664
    E.1.2Term Diabetic 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 the study is to investigate, whether DPOCL (DermaPro®), a solution designed for healing of diabetic foot ulcers when administered into the open wound shows clinical efficacy in comparison to a 0.9% physiological saline solution.

    Two criteria will be evaluated:

    1.The reduction of wound size from baseline to last visit (primary variable 1)
    2. The percentage of patients with wound closure (defined as the wound area entirely covered with connective tissue) and sustained wound closure 4 weeks after initial wound closure and cessation of treatment (i.e. healing rate). (primary variable 2)

    Hypothesis 1: Under treatment of DPOCL reduction of wound size and potentially in addition healing rate is improved compared to 0.9% physiological saline solution.

    E.2.2Secondary objectives of the trial
    Time from onset of treatment until wound closure

    Percentage of patients with 50% reduction in baseline wound area after 4, 8 and 12 weeks of treatment.

    Percentage of patients with 90% or more wound closure at week 12 and cessation of study treatment, achieving wound closure after a further 4 weeks without study treatment.

    Safety characteristics of DermaPro® considering Adverse Events, (with particular highlighting of infectious adverse events), laboratory parameters and vital signs

    Characterisation of subjective symptoms using visual analogue scores (VAS) for pain, itching, and well-being

    Evaluation of subjective clinical symptoms (prickling, heat and cold sensation, numbness, furry feeling, smell, exudation)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diabetic foot ulcer with mean diameter between 1.5 and 5 cm after débridement (if indicated) using the formula (longest length + longest width)/2. Wound shapes other than circular must have a both 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 for at least 4 weeks unsuccessfully

    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.

    Diabetes mellitus with HbA1c ≤ 12% and patient is under optimal control of blood glucose

    Adequate perfusion of the lower leg (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
    E.4Principal exclusion criteria
    - Local antibiotic therapy of the target wounds selected for the study
    - Suspicion of bone infection or osteomyelitis affecting the area of target wound
    - Peripheral arterial occlusive disease in the pelvic region or lower extremities
    - Vascular reconstruction or angioplasty less than 3 months ago or planned revascularization procedure
    - Start or change of a new off-loading strategy (already existing off-loading device is optimally applied and must be kept)
    - 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 in the tolerated ranges given in Section 15.5.1
    - Severe or uncontrolled heart disease (NYHA class III or IV)
    - Renal failure or treatment with dialysis
    - Severe hepatic disease
    - 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)
    - Previous radiation of the region of the target wounds selected for the study
    - Exposure of any systemic immunosuppressive or cytostatic therapy during the previous 30 days prior to the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the study is to investigate, whether DPOCL (DermaPro®), a solution designed for healing of diabetic foot ulcers when administered into the open wound shows clinical efficacy in comparison to a 0.9% physiological saline solution.

    Two criteria will be evaluated:

    1.The reduction of wound size from baseline to last visit (primary variable 1)
    2. The percentage of patients with wound closure (defined as the wound area entirely covered with connective tissue) and sustained wound closure 4 weeks after initial wound closure and cessation of treatment (i.e. healing rate). (primary variable 2)


    E.5.1.1Timepoint(s) of evaluation of this end point
    Determination of reduction of wound size .
    Determination of percentage of patients with wound closure (defined as the wound area entirely covered with connective tissue) sustained for 4 weeks, after initial wound closure and cessation of treatment .
    E.5.2Secondary end point(s)
    The reduction at all time points has to be analysed.

    The relative reduction of wound area* (%) (= reduction / baseline *100) will be analysed.

    The influence of DPOCL treatment on the course of HbA1c will be investigated.

    Visual Analogue Scores (VAS) of pain, itching, and well-being.

    Subjective clinical symptoms (prickling, heat sensation, cold sensation, numbness, furry feeling, smell, exudation) will be evaluated descriptively. The relative frequency (%) of patients with an improvement, no change, or a deterioration of each symptom will be given. Additionally, a total symptom score shall be calculated as the sum of the subjective clinical symptoms (prickling, heat sensation, cold sensation, numbness, furry feeling, smell, exudation).

    Adverse Events (AE) will be listed and evaluated descriptively with regard to intensity, drug relationship, outcome, treatment, action taken and seriousness. AE incidence will be compared between the treatment groups using a two-sided Fischer Exact test.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See above.
    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) 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Ukraine
    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 years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 270
    F.4.2.2In the whole clinical trial 300
    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)
    Patients who complete the study will be further treated by their physician in accordance with the clinical routine of the site and upon further discretion of the responsible physician.
    Patients exhibiting either subjective or objective abnormalities when the study has been completed will be followed up.
    Any AE which remains unsolved after completion of the study requires detailed evaluation and follow-up until AE has been resolved or a reasonable explanation for its persistence is found.
    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 Decision2014-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-30
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