Clinical Trial Page

Summary
EudraCT Number:2010-020437-12
Sponsor's Protocol Code Number:DT-DP-D2b
National Competent Authority:Latvia - SAM
Clinical Trial Type:EEA CTA
Trial Status:Prematurely Ended
Date on which this record was first entered in the EudraCT database:2011-07-06
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
A. Protocol Information
A.1Member State ConcernedLatvia - SAM
A.2EudraCT number2010-020437-12
A.3Full title of the trial
A multicentric, double blind, randomized, comparative Phase II b study of the efficacy of a wound healing solution in patients with diabetic foot ulcer
A.4.1Sponsor's protocol code numberDT-DP-D2b
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 support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
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.3.11 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 Infusion
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntralesional use
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
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 14.0
E.1.2Level LLT
E.1.2Classification code 10012664
E.1.2Term Diabetic foot ulcer
E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
Investigation of clinical efficacy of DermaPro® after administration into the unhealing, open diabetic wounds characterised by reduction of wound area after 30, 60 and 90 days of treatment, time from onset of treatment until healing e.g. wound area covered entirely with connective tissue
E.2.2Secondary objectives of the trial
Characterisation of safety of DermaPro® considering 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 sensation, cold sensation, numbness, furry feeling, smell, exudation) Investigation of clinical efficacy of DermaPro® concerning reduction of wound depth and wound volume during treatment Investigation of clinical efficacy of DermaPro® in terms of fractions of patients with 50% reduced wound area after 30, 60 and 90 days of treatment
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
·Gender: male/female (of non-childbearing potential defined as being amenorrhoeic for longer than 2 years with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms) (1)
·Age: from 18 to 80 years to be included (2)
·Diabetic foot ulcer diameter in between 1,5-3,5cm after débridement (if indicated) wound stage Wagner grade I or II, Armstrong stadium A-C (for Wagner-Armstrong-Classification see Appendix 1) (3)
·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)
·Diabetes mellitus; HbA1c to be controlled (5)
·Adequate perfusion of lower leg as determined for instance by the ankle brachial pressure index (>0.5), or by a more precise method (e.g. TcPO2 > 30 mmHg, pelvic/leg angiography, duplex sonography in discretion of the
investigator) to exclude patients who require a revascularization therapy, examination results should be not older than 3 months (6)
·The patient must give written informed consent, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the patients participating in the study (7)
E.4Principal exclusion criteria
·Local antibiotic therapy of the target wounds selected for the study (1)
·Suspicion of bone infection or osteomyelitis affecting the area of target wound (2)*
·Severe peripheral arterial occlusive disease in the pelvic region or lower extremities (3)
·Vascular reconstruction or angioplasty less than 3 months ago or planned revascularization procedure (4)
·Inability or unwillingness to be fitted with appropriate shoe gear or an off-loading device (if required) (5)
·Clinically significant abnormal laboratory values except those typical for the underlying diseases mentioned in the inclusion criteria (6)
·Severe or uncontrolled heart disease (7)
·Severe renal failure treated with dialysis (8)
·Severe hepatic disease (9)
·Concurrent illness or a condition that may interfere with wound healing other those mentioned in the inclusion criteria (e. g. carcinoma, haematological disease, vasculitis, connective tissue disease, alcohol neuropathy; history of or current drug or alcohol abuse) (11)
·Previous radiation of the region of the target wounds selected for the study (12)
·Exposure of any systemic immunosuppressive or cytostatic therapy during the previous 30 days prior to the study, this refers also to any kind of glucocorticoids (13)
·Severe psychiatric or neurological disorder (14)
·Incapability of giving informed legal consent (15)
·Co-worker, student, relative or spouse of the investigator (16)
·Participation in the study already before (17)
·Participation in another experimental clinical trial during the previous 30 days prior to the present study (18)
·HbA1c >9,5% If the patient does not meet this inclusion criterion, randomisation may be delayed and screening visit may be repeated. (19)
E.5 End points
E.5.1Primary end point(s)
Reduction of wound area after 30, 60, and 90 days of treatment in %, descriptive statistics (arithmetic and geometric means, CV, medians, min, max, SD)
Time from start of treatment to entire closure of wound (arithmetic and geometric means, CV, medians, min, max,
SD)
Analysis of primary variables in terms of treatment effect is performed using mixed models (ANCOVA) including baseline covariate and addressing repeated measures by simple covariance patterns
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) 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
multi dose
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.8.3 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 concerned3
E.8.5The trial involves multiple Member States Yes
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
Last visit of the last subject
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years
E.8.9.1In the Member State concerned months9
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial months9
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.1.3Elderly (>=65 years) Yes
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 state50
F.4.2 For a multinational trial
F.4.2.1In the EEA 120
F.4.2.2In the whole clinical trial 120
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 Decision2011-08-18
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2011-07-28
P. End of Trial
P.End of Trial StatusPrematurely Ended

Sponsors and Collaborators

Medical Conditions

Drug Interventions

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