E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
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 | 10056340 | E.1.2 | Term | Diabetic ulcer | |
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. | |
E.2.2 | Secondary objectives of the trial | The second end point is to confirm the safety and the tolerability of the active compound. | |
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 Patients foot ulcer been present for a minimum of 2 weeks under the current investigators care Patients foot ulcer size: 1.0 cm2 and < 16.0 cm 2 at day 0 Patients ulcer grade 1 or 2 of Wagner scale Patients 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. | |
E.4 | Principal exclusion criteria | The presence of one or more of the following criteria will exclude the patient from the trial: 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 Patients 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. | |
E.5 End points |
E.5.1 | Primary end point(s) | 1.Complete wound closure (100%) | |
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 | 8 |
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 | |
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 | 3 |
E.8.9.1 | In the Member State concerned days | |