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    Summary
    EudraCT Number:2017-004527-67
    Sponsor's Protocol Code Number:DT-DP-DFU-CR-04
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-03-19
    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 ConcernedEstonia - SAM
    A.2EudraCT number2017-004527-67
    A.3Full title of the trial
    A Randomised Dose Finding Study Comparing The Safety And Efficacy Of three blinded doses of Diperoxochloric Acid (DPOCl, DermaPro®) and A Standard Moist Wound Dressing 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
    DermaPro® versus standard moist wound dressing in patients with diabetic foot ulcers
    A.4.1Sponsor's protocol code numberDT-DP-DFU-CR-04
    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 Trials Information
    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
    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 IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDiperoxochloric acid sodium salt
    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 number1.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDiperoxochloric acid sodium salt
    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 number2.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDiperoxochloric acid sodium salt
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic foot ulcer with mean diameter between 1.5 and 4 cm after débridement if indicated),
    Wound stage Wagner grade I or II, Armstrong stadium A or C (for Wagner-Armstrong-Classification), treated unsuccessfully for at least 4weeks.
    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
    To assess which of three DPOCl doses is most effective compared to reference treatment in reducing wound sizes in the tested sample patient populations
    E.2.2Secondary objectives of the trial
    • Wound area reduction (change between last visit and baseline), as measured by computerised wound area determination.
    • Percentage of patients achieving complete wound closure.
    • Time to complete wound closure
    • Sustainability of wound closure within the 12 week treatment time frame.
    • Course of wound closure over time.
    • Improvement of subjective symptoms (itching, pain, well-being using Visual Analogue Scores (VAS))
    • Improvement of objective clinical symptoms (prickling, heat sensation, cold sensation, numbness, furry
    feeling, smell, exudation)
    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 treated unsuccessfully for at least 4weeks.
    Should more than one eligible wound be present, only one will be selected (“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 extremity determined by 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.Local antibiotic therapy of the target wound selected for the study.

    2.Suspicion of bone infection or osteomyelitis* affecting the area of target wound.

    3.Peripheral arterial occlusive disease in the pelvic region or lower. Note: The ulcer is primarily ischemic in etiology as diagnosed by an ABI of ≤ 0.7 on the affected extremity extremities or systolic pressure of ≤ 50 mmHg (great toe) or ≤ 70 mmHg (dorsalis pedis).

    4.Vascular reconstruction or angioplasty less than 3 months ago 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 (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 Section 11.3.8.
    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.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, hematological disease, vasculitis, connective tissue disease, alcohol neuropathy).
    11.Previous radiation of the region of the target wound selected for the study.
    12.Exposure to any systemic immunosuppressive or cytostatic therapy 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)
    Wound area reduction (percentage change between last visit and baseline as compared to baseline), as measured by computerised wound area determination
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weekly
    E.5.2Secondary end point(s)
    • Wound area reduction (change between last visit and baseline), as measured by computerised wound area determination.
    • Percentage of patients achieving complete wound closure.
    • Time to complete wound closure
    • Sustainability of wound closure within the 12 week treatment time frame.
    • Course of wound closure over time.
    • Improvement of subjective symptoms (itching, pain, well-being using Visual Analogue Scores (VAS))
    • Improvement of objective clinical symptoms (prickling, heat sensation, cold sensation, numbness, furry feeling, smell, exudation)
    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 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 Yes
    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) No
    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 Yes
    E.8.1.7.1Other trial design description
    3 blinded doses of IMP versus comparator
    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
    Hartmann Hydrosorb® dressing
    E.8.2.4Number of treatment arms in the trial4
    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 EEA7
    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
    Estonia
    Georgia
    Latvia
    Ukraine
    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
    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 months5
    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 months5
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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 treatment
    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 Decision2018-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-27
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