E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients suffering from Dabetic Foot Ulcer (DFU) of neurophatic origin. |
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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 | 10012664 |
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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 demonstrate a superior wound closure rate of DFUs of neuropathic origin after 12 weeks topical daily application of trafermin 0.01% spray compared with placebo, in addition to best local care. Wound closure is defined as 100% reepithelialization of the target DFU (i.e the target wound only), without drainage. |
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E.2.2 | Secondary objectives of the trial |
•To determine the time to reach complete wound closure. •To determine absolute and relative wound area regression and wound edge migration based on planimetry tracing. •To determine the occurrence rate of clinical infection on the target DFU. •To evaluate the safety of trafermin 0.01% spray. •To determine the rate of amputations on the target DFU. •To determine the frequency of local mechanical or surgical procedures. •To determine the maintenance of wound closure/time to re-opening up to 3 months after observed reepithelialization. •To determine DFU new occurrence/recurrence up to 12 months. •To assess high sensitivity C-Reactive Protein (hs CRP) level variations. •To explore biomarkers from target wound fluid (selected centers only). •To explore the correlation of absolute and relative wound area regression and wound |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Provide written informed consent to participate. 2. Male or female patients age 18 years or older. 3. Type 1 or 2 diabetes. 4. A single full-thickness DFU that has been present for at least 2 weeks. 5. DFU wound surface area ≤34 cm2 on the target foot. 6. No exposure of bone in the target DFU. 7. Neuropathy confirmed by loss of protective sensation to monofilament test (Semmes- Weinstein 5.07 monofilament according to diagnostic criteria presented in Appendix 5). 8. ABPI on the leg with the target DFU ≥0.7 and ≤1.3 and toe blood pressure >40 mmHg (to exclude predominant ischemia requiring further exploration and treatment). |
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E.4 | Principal exclusion criteria |
1. Active Charcot foot, or inactive Charcot foot, if the target DFU cannot be properly offloaded. 2. Ulcers of non-neuropathic origin (e.g., rheumatoid, radiation-related, vasculitis-related ulcers). 3. Presence of any foot ulcer (whether or not on the target foot) for which local or systemic antibiotic treatment is required. 4. Evidence of skin cancer within or adjacent to the target ulcer. 5. Any infected ulcers, defined as any problem such as (but not limited to) cellulitis, osteomyelitis, gangrene, or deep tissue infection requiring local or systemic antibiotic therapy. 6. Another wound on the same limb as the target DFU, even if the other wound does not involve the foot. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Wound closure is defined as observed 100% reepithelialization of the target DFU, without drainage, confirmed by a second medical evaluation after two weeks. The wound closure rate is the number of patients achieving wound closure at the specified timepoint during the 12-week double blind treatment period. |
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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 | 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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
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 | 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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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 | 6 |
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 |