E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetic neuropathic foot ulcer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012664 |
E.1.2 | Term | Diabetic foot ulcer |
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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 |
To compare the efficacy of DERMAGEN® versus the conventional treatment (sterile saline-moistened gauze) for the treatment of patients with diabetic neuropathic foot ulcer. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of DERMAGEN® |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Female or male patient aged ≥ 18 • Patient with documented and stable* type I or II diabetes mellitus • With diagnosis of neuropathic foot ulcer located on the plantar surface of the forefoot • Ulcer with a surface area comprised between 1 and 15 cm2 included (after mechanical debridement of the ulcer) • Palpable pulse evidenced on both feet (presence of dorsalis pedis pulse and posterior tibial pulse) or in absence of one pulse, a Systolic Pressure Index (SPI) by Doppler > 0.9 on the target limb • Presence of diabetic foot ulcer for at least 4 weeks prior to enrolment • Patient’s ulcer extending through the dermis without exposure of muscle, tendon, bone, or joint capsule *means confirmed by HbA1C at least every 4 months
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E.4 | Principal exclusion criteria |
• Typical Charcot’s foot • Decrease or increase in the size of the ulcer by 50% or more during the run-in period • Presence of osteitis (eq Br osteomyelitis) at the inclusion visit (evidenced with a radiological lesion facing the wound (bone erosion or disappearance of the cortical bone)) • Clinical evidence of Pedis grade 3, or 4 infection at the inclusion visit • Patient who cannot have an off-loading method • Patient with working activity who cannot be on sick-leave during the study period. • Patient presenting a known allergy to collagen, streptomycin, penicillin and/or products of bovine origin • Dialysed patient • Patient suffering from a psychiatric disorder not treated • Clinical evidence of gangrene on any part of the affected foot • Patient receiving corticosteroids, NSAIDs, immunosuppressive or cytotoxic agents, all systemic agents that can affect wound repair or any treatment that might interfere with the assessment of the study treatment
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E.5 End points |
E.5.1 | Primary end point(s) |
Healing rate (complete wound closure) at week 12 |
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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 | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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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 |
conventional treatment (saline-moistened gauze) |
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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 | 26 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 45 |
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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Last Semester 2010 The study end is defined as the last visit of the last patient.
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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 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |