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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-000692-15
    Sponsor's Protocol Code Number:05-DFU-001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-04-27
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-000692-15
    A.3Full title of the trial
    A prospective single centre, open label, pilot study to evaluate the safety of ICXP007 plus standard of care, for the treatment of lower extremity chronic, neuropathic diabetic foot ulcers
    A.3.2Name or abbreviated title of the trial where available
    DFU I
    A.4.1Sponsor's protocol code number05-DFU-001
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIntercytex
    B.1.3.4CountryUnited Kingdom
    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 Information not present in EudraCT
    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 nameICXP007
    D.3.2Product code ICXP007
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeHDF
    D.3.9.3Other descriptive nameHuman dermal Fibroblasts
    D.3.10 Strength
    D.3.10.3Concentration number3 x 10e6 cells
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    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
    The primary safety objective is to determine the safety of ICXP007 plus standard of care in the treatment of chronic diabetic foot ulcers.

    The primary efficacy objective is to determine the efficacy of ICXP007 plus standard of care in achieving complete ulcer closure at 12 weeks in chronic, neuropathic diabetic foot ulcers of greater than four weeks duration.
    E.2.2Secondary objectives of the trial
    The secondary efficacy objectives are to evaluate

    1. complete ulcer closure by week 24
    2. time to achieve complete ulcer closure
    3. rate of ulcer healing
    4. relative ulcer area from baseline to week 24
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Signed IRB approved informed consent obtained prior to the first study intervention.
    2. Age equal to or greater than 40 and less than 85 years old at the time the informed consent is signed.
    3. Subjects will have a diabetic ulcer on the lower extremity, with the ulcer having all of the following characteristics:
    a. Full-thickness plantar ulcers.
    b. Non-infected as determined by clinical assessment.
    c. Neuropathic as determined by neuro disability score 6 or more.
    d. Area greater than or equal to 1.0 cm squared and less than or equal to 20.0 cm squared post debridement.
    e. Has been present for at least 4 weeks under observation at the time of enrollment.
    f. Extends through the dermis but without tendon, muslce, capsule or bone exposure.

    4. Subjects will have either insulin-dependent or non-insulin-dependent diabetes mellitus with a HbA1c value in the range of 6% to 12%.
    5. The ulcer bed at the time of enrollment must be free of all necrotic and infected soft and bony tissue as determined by clinical examination (no evidence of probing to bone).
    6. Ankle-brachial systolic pressure index greater than 0.7 and palpable foot pulses.
    E.4Principal exclusion criteria
    1. Malignant or connective tissue disease.
    2. Individuals who have received short course corticosteriods within 30 days, or oral or parenteral chronic immunosupressants within 90 days prior to treatment.
    3. Individuals with a known hypersensitivity to Aprotinin or any other constituents of Tisseel VH S/D TM i.e. Fibrinogen (human), thrombin (human) and calcium chloride, bovine and porcine products.
    4. Individuals who have a target ulcer which shows signs of clinical infection as determined by clinical examination.
    5. Active febrile illness (fever greater than or equal to 38.0 degrees centigrade)
    6. Renal or liver impairment as indicated by serum creatinine levels and liver function tests three or more times higher than normal values.
    7. Subject has an active Charcot as determined by clinical examination (new local pain, evidence of swelling and warmth).
    8. Subjects who refuse or who are unable to participate in all screening procedures, or to comply with the requirements of the study.
    9. Use of other investigational products at the time of enrolment or during the study.
    10. The use of any topical treatments, other than SOC, in or on the surface of the target ulcer at the time of enrolment.
    11. Subjects who have been enrolled in any investigational clinical trial within 30 days of the screening visit.
    12. Recent or current history of alcohol or drug abuse.
    13. Females who are pregnant, lactating, or who have not reached menopause and are not abstinent or practising an acceptable means of birth control as determined by the investigator for the duration of the study.
    14. Subjects who have critical limb ischemia.
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints: Incidence of adverse events, adverse reactions, osteomyelitis, ulcer infections and serious adverse events.

    Efficacy endpoint: Healing assessed by incidence of 100% closure (epithelialised) by week 12.
    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 Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    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 months6
    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.1.3Elderly (>=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 Information not present in EudraCT
    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 2006-04-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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.3.3.6.1Details of subjects incapable of giving consent
    Women of child bearing potential must be practising an acceptable method of birth control as deemed by the investigator for the duration of the study.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    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 Decision2006-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-03-20
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