E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Venous leg ulcer (ulcus cruris) |
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E.1.1.1 | Medical condition in easily understood language |
a chronic non healing wound located below the knee |
eine chronische nicht heilende Wunde |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045346 |
E.1.2 | Term | Ulcerated varicose veins |
E.1.2 | System Organ Class | 100000004866 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Percentage of complete wound closure |
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E.2.2 | Secondary objectives of the trial |
Percentage of patients with at least 50% wound reduction Absolute wound reduction Improved subjective symptoms |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. The patient must give written informed consent, after having been informed about the benefits and potential risks of the study, as well as details of the insurance taken out to cover the patients participating in the study 2. Age: >18 years, inclusive 3. One or more chronic venous foot ulcer (ulcus cruris) between knee and ankle (lower leg) with a mean area of at least 4.0 and a maximum of 60 cm² after debridement (if indicated).. Wound shapes other than circular must have a both length and width of at least 2.0 cm, 4. Clinical findings consistent with established venous disease (such as skin hyperpigmentation, hypopigmentation, varicose veins, lipodermatosclerosis) confirmed by venous Doppler duplex ultrasonography. 5. If other ulcerations are present at the same leg, they must be >2cm apart from the target wound 6. Adequate perfusion of the lower leg as determined by an ABI > 0.85 for the leg to be treated 7. Females of non-childbearing potential defined as being amenorrheal 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.
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E.4 | Principal exclusion criteria |
1. New ulcers (first appearance less than 4 weeks) or ulcers, which have been treated over the last 4 weeks and showed a reduction of wound size of > 25% 2. Target wound showed healing tendency between screening and enrolment 3. Local antibiotic therapy of the target wounds selected for the study 4. Known or suspicion of osteomyelitis at the target leg 5. Other wounds of different aetiology with impaired healing, such as decubitus ulcer, arterial and/or diabetic foot 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. 6. Vascular reconstruction or angioplasty less than 3 months ago 7. Clinically significant abnormal values in clinical chemistry o Advanced renal failure (Creatinine >2mg%) o Severe hepatic disease (3 times above upper normal limit) o Uncontrolled Diabetes mellitus (HbA1c >9%). o Significant anaemia (Hb < 10g/dl), o Albumin <2,5g/dl 8. Severe or uncontrolled heart failure (NYHA class III or IV) 9. BMI > 45.0 kg/m² 10. Patient is not ambulatory 11. 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) 12. Previous radiation of the region of the target wounds selected for the study 13. Exposure of any systemic immunosuppressive or cytostatic therapy during the previous 6 months days prior to the study 14. Severe psychiatric or neurological disorder 15. Incapability of giving informed legal consent 16. Unsuitable circumference of ancle and/or wade (as defined in section 17.3) preventing adequate compression treatment 17. Co-worker, student, relative or spouse of the investigator 18. Previous participation in the study 19. Participation in another experimental clinical study during the previous 30 days prior to the present study 20. Current drug or alcohol abuse
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E.5 End points |
E.5.1 | Primary end point(s) |
1) Percentage of patients achieving complete wound closure 2) Percentage of patients achieving at least >50% wound closure 3) Overall % reduction of wound size at the end of treatment 4) Time to complete wound closure 4) Time to >50% wound closure 5) Subjective symptom relief 6) reduction od wound size at week 4,8,12 , and 16 weeks |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
time of complete wound closure end of treatment after 16 weeks |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
after 16, 12 ,8 and 4 weeks |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
0.9 physiologic NaCl Solution |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Germany |
Latvia |
Lithuania |
Ukraine |
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E.8.7 | Trial 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
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The trial is individually terminated either at the end of treatment period (week 16) or when wound closure is achieved, what ever comes first. Patients not showing wound improvement after 4 weeks of treatment will be excluded from the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |