E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetic Foot Ulcer |
Ulcera del piede diabetico |
|
E.1.1.1 | Medical condition in easily understood language |
Diabetic Foot Ulcer |
Ulcera del piede diabetico |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 24.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012664 |
E.1.2 | Term | Diabetic foot ulcer |
E.1.2 | System Organ Class | 100000004858 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 24.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012664 |
E.1.2 | Term | Diabetic foot ulcer |
E.1.2 | System Organ Class | 100000004858 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 24.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012664 |
E.1.2 | Term | Diabetic foot ulcer |
E.1.2 | System Organ Class | 100000004858 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 24.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012664 |
E.1.2 | Term | Diabetic foot ulcer |
E.1.2 | System Organ Class | 100000004858 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 24.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012664 |
E.1.2 | Term | Diabetic foot ulcer |
E.1.2 | System Organ Class | 100000004858 |
|
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 determine the safety, tolerability, and pharmacokinetic profile of udonitrectag (MT8) added to standard of care versus standard of care alone in the treatment of Diabetic Foot Ulcers. |
Valutare la sicurezza, la tollerabilità e il profilo farmacocinetico di due differenti dosi di udonitrectag (MT8) in aggiunta a terapia standard nel trattamento delle ulcere del piede diabetico rispetto alla sola terapia standard. |
|
E.2.2 | Secondary objectives of the trial |
To determine and to compare the ability of two doses of udonitrectag in promoting reduction of the ulcer area during 6-week treatment. |
Determinare e confrontare la capacità di due dosi di udonitrectag nel promuovere la riduzione dell'area dell'ulcera durante il trattamento di 6 settimane. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Provision of signed and dated informed consent form; 2. Stated willingness to comply with all study procedures and availability for the duration of the study; 3. Male or female; 4. Age = 18 years; 5. Diagnosis of type 1 or 2 diabetes mellitus; 6. A diabetic foot wound grade I or II, according to the TEXAS diabetic wound classification system (Table 5) and grading 1 in the PEDIS infection scale (Table 6); 7. TpO2= 30 mmHg or ABI (Ankle Brachial Index) = 0.70; 8. Ulcers not healing with standard good care in the last 2-weeks (ulcer area reduction less than 20% versus baseline); 9. Presence of ulcer with an area from 2 to 15 cm2 measured by MolecuLight i:XTM Wound Imaging Device; 10. Females of childbearing potential must have a negative urine pregnancy test prior to commencing the study; 11. Glycated haemoglobin (HbA1c) levels =10% (or = 86 mmol/mol); 12. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation; 13. For males with partners reproductive potential: use of condoms or other methods to ensure effective contraception with partner. |
1. Modulo di consenso informato firmato e datato. 2. Dichiarata disponibilità a rispettare tutte le procedure dello studio e disponibilità per tutta la durata dello studio. 3. Maschio o femmina 4. Età =18 anni. 5. Diagnosi di diabete mellito di tipo 1 o 2. 6. Una ferita diabetica al piede di grado I o II, secondo il sistema di classificazione delle ferite diabetiche TEXAS e di grado I nella classificazione PEDIS. 7. Indice TpO2 =30 mmHg o ABI =0.70. 8. Ulcere che non guariscono con un buon trattamento standard nelle ultime 2 settimane (riduzione dell'area ulcerosa inferiore al 20% rispetto al basale). 9. Presenza di ulcera con un'area da 2 a 15 cm2 misurata mediante MolecuLight i:XTM Wound Imaging Device. 10. Le femmine in età fertile devono avere un test negativo di gravidanza nelle urine prima di iniziare lo studio. 11. Livelli di emoglobina glicata =10% (or = 86 mmol/mol). 12. Per le femmine in età riproduttiva: uso di una contraccezione altamente efficace per almeno 1 mese prima dello screening e accordo per l'uso di tale metodo durante la partecipazione allo studio. 13. Per i maschi con partner in età riproduttiva: uso di preservativi o altri metodi per garantire una contraccezione efficace con il partner per tutta la durata dello studio. |
|
E.4 | Principal exclusion criteria |
1. Pregnancy or Lactation. Female patients who are pregnant or breast-feeding; 2. Childbearing potential female patients who do not agree to use an acceptable method of contraception during the study, providing they are not pregnant or lactating; 3. Presence of infected foot ulcer of grade >1 (according to the PEDIS diabetic foot ulcer classification system), diagnosed via a clinic examination; 4. Participation in any other clinical trial or currently receiving any other investigational product(s) within 30 days prior to study treatment (Visit 1a o Visit 1b); 5. Severe renal failure defined as eGFR< 30 ml/min; 6. Clinical diagnosis of peripheral vascular disease (PVD) requiring a prompt revascularization; 7. Any surgery planned in the study period, including scheduled amputation at the ulcer site; 8. Diagnosis of severe medical conditions such as severe heart failure or severe hepatic disease, according to the Investigator’s judgment or presence of concurrent illness indicating a short life expectancy; 9. Diagnosis of current cancer; 10. Diagnosis of current of autoimmune disorders; 11. Immunosuppressed subjects; 12. History of any medical or psychiatric conditions that, according to the Investigator, may increase the risks associated with the study’s participation or investigational product(s) administration; 13. Patients with diabetes under poor control (HbA1c of >10% or >86 mmol/mol); 14. Patients with ulcers due to other etiologies (e.g., arterial insufficiency); 15. Current use of high-dose steroids or immunosuppressants; 16. Febrile illness within one month from Visit 1b; 17. Current smoker; 18. Blood pressure above 180/100 or heart rate>100 bpm or Respiratory frequency >30; 19. Patients who show reductions or enlargement of the ulcer area >20% during the screening phase will not be enrolled for the study. |
1. Pazienti in gravidanza o in allattamento. 2. Pazienti in età fertile che non accettano di utilizzare un metodo di contraccezione accettabile per la durata dello studio. 3. Presenza di ulcera del piede infetta di grado >1 (secondo il sistema di classificazione dell'ulcera del piede diabetico PEDIS), diagnosticata tramite esame clinico. 4. Partecipazione a qualsiasi altro studio clinico o essere in trattamento con qualsiasi altro prodotto o prodotti sperimentali nei 30 giorni prima di ricevere il trattamento sperimentale. 5. Grave insufficienza renale definita come eGFR< 30 ml/min. 6. Diagnosi clinica di malattia vascolare periferica che richiede una pronta rivascolarizzazione. 7. Qualsiasi intervento chirurgico pianificato nel periodo di studio, compresa l'amputazione programmata nel sito dell'ulcera. 8. Diagnosi di gravi condizioni mediche come grave insufficienza cardiaca o grave malattia epatica, secondo il giudizio dello sperimentatore, o la presenza di malattia concomitante che indica una breve aspettativa di vita. 9. Diagnosi di cancro/neoplasia. 10. Diagnosi di malattie autoimmuni. 11. Soggetti immunosoppressi/immunodeficienti. 12. Storia di qualsiasi condizione medica o psichiatrica che, secondo il giudizio dello sperimentatore, possa aumentare i rischi associati alla partecipazione allo studio o alla somministrazione di prodotti sperimentali. 13. Pazienti con diabete con inadeguato controllo metabolico definito come HbA1c >10% o >86 mmol/mol. 14. Pazienti con ulcere dovute ad altre eziologie (ad esempio, insufficienza arteriosa). 15. Uso corrente di steroidi ad alte dosi o immunosoppressori. 16. Malattia febbrile entro un mese dall’inizio dello studio. 17. Attuale fumatore. 18. Pressione sanguigna superiore a 180/100 mmHg o frequenza cardiaca>100 bpm o frequenza respiratoria >30. 19. Pazienti che mostrano riduzione o ampliamento dell'area dell’ulcera >20% durante la fase di screening. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Safety and tolerability: I. Nature, frequency, severity, and timing of adverse events including skin irritation, haematological, hepatic, and renal events; II. Clinical laboratory results during and following udonitrectag administration; III. Pharmacokinetics. |
Sicurezza e tollerabilità: I. Natura, frequenza, gravità e tempistica di eventi avversi tra cui irritazione cutanea, eventi ematologici, epatici e renali; II. Risultati clinici di laboratorio durante e dopo il trattamento con udonitrectag; III. Farmacocinetica. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Efficacy: percentage of ulcer area reduction during 6-week treatment, defined as percentage change area ((Area0 - Areat)/Area0)*100. |
Efficacia: percentuale di riduzione dell'area ulcerosa durante il trattamento di 6 settimane, definita come area di variazione percentuale ((Area0 - Areat)/Area0)*100 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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) | Yes |
E.7.1.1 | First administration to humans | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Terapia standard |
Standard of care |
|
E.8.2.4 | Number of treatment arms in the trial | 3 |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |