E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic, refarctory, non-healing venous ulcers with a duration of more than two years. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047260 |
E.1.2 | Term | Venous ulceration |
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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 |
The primary objective of this trial is to evaluate the safety and efficacy of topical wound oxygen in managing refractory venous ulcers, at both the clinical and molecular levels. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to compare the outcome of TWO to that of compression dressings in terms of: 1. proportion of fully healed ulcers 2. The time required for compete ulcer closure or time to skin grafting 3. The change in ulcers surface area 4. The degree of beacterial elimination 5. Changes in quality of life 6. The dgree of pain reduction 7. Ulcer recurrance rate 8. The up-regulation of angiogenesis related growth factors |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Aged 18 years or more 2. Written informed consent 3. Venous ulcers present, with durationof more than two years 4. No sign of improvement or healing of the relevant ulcer over past year prior to screening 5. A C6 grading in the CEAP classification
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E.4 | Principal exclusion criteria |
1. Pregnant & lactating women 2. Involvment in another clinical trial in the previos six months 3. Legal incapacity 4. Pateint is bed-ridden 5. Ischaemic ulcer/s present 6. Diabetic ulcer/s present 7. refusal to refrain from smoking 8. Malignant ulceration/s 9. Ulcer exposing bone or tendon 10. Osteomyelitis 11.Pseudomonas infection 12. Presence of gangrene 13. Deep venous thrombosis (DVT) present 14. Connetive tissue disease present 15. Presence of any illness that could limit long-term compliance (e.g. epilepsy)
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the proportion of index ulcers fully healed after 12 weeks of therapy. |
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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) | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Smith & Nephew Profore Compression dressings |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial 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
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The trial is formally ended when the last subject recruited has completed 12 weeks in the trial. Ethics committte and IMB will then be notfied according to regulations. However, to capture data on long-time efficacy and safety there will be another follow up at 6 weeks, three months, 6 months and 12 months after completion of therapy. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |