E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 main objective of this clinical trial is to evaluate the efficacy of the polydeoxyribonucleotide (active drug) in improving the healing of diabetic foot ulcers |
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E.2.2 | Secondary objectives of the trial |
The second end point is to confirm the safety and the tolerability of the active compound |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male and female patients must be aged between 45 and 80 years. Minimum schooling 5 years. Patient with type I or II diabetes since at least 5 years, with a stable metabolic picture Patient’s foot ulcer been present for a minimum of 2 weeks under the current investigator’s care Patient’s foot ulcer size: 1.0 cm2 and < 16.0 cm 2 at day 0 Patient’s ulcer grade 1 or 2 of Wagner scale Patient’s wound free of necrotic debris and appears to be made up of healthy vascularized tissue Patient with adequate circulation to the foot as evidenced by: transcutaneous oxygen tension (TcPO2) measured at the dorsum of the foot exhibiting the ulcer and or >29 mmHg and/or ankle/brachial blood-pressure index >0,9 If female, she will not be pregnant nor lactating. In case of sexual acts, she agrees to use appropriate contraceptive measures during the whole study period. All patients must give their written, informed consent.
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E.4 | Principal exclusion criteria |
Non-consenting patient who have not given their written consent to participation in the trial. History of alcohol or drug abuse. Pregnancy and lactation. Gangrene on any part of the affected foot Ongoing infection without treatment Patient’s ulcer over a Charcot deformity Ulcer total surface area: >16 cm2 Patient with a non-study ulcer on the study foot that is located within 7.0 cm of the study ulcer at day 0 Patient who at present or during the last month took part in another clinical study. Patient taking at present or in the last 10 days systemic cicatrizant drugs Patient suffering of severe malnutrition Patients receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents Signs and symptoms of neurological and/or psychiatric pathologies requiring treatment. Severe liver or kidney insufficiency. Other severe, ongoing pathologies of an internal or surgical nature. Proven hypersensitivity to polydeoxyribonucleotide or related drugs. Patient whom the Investigator deems to be unhelpful or unreliable for the purposes of the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 24 |