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SNCTP000004329 | NCT03588130 | BASEC2020-02975

Étude pour évaluer l'efficacité et l'innocuité d'EscharEx (formulation EX-02) dans le débridement des ulcères veineux de jambe

Base di dati: BASEC (Importata da 29.11.2021), WHO (Importata da 18.04.2021)
Cambiato: 19.10.2021
Categoria di malattie: Malattie arteriose e venose incluse la trombosi venosa profonda e l'embolia polmonare

Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)

Cette étude inclura des patients présentant des ulcères veineux de jambe chez qui la plaie n'est pas cicatrisée depuis au moins 4 semaines. Les participants seront assignés au hasard dans un ratio 2:2:1 à l'un des trois groupes de traitement suivants:
- Un groupe qui recevra le produit testé, EscharEx-02
- Un groupe qui recevra le produit sans principe actif, le Gel
- Un groupe qui recevra un traitement par un standard de soin non-chirurgical choisi par le médecin de l'étude
La durée maximale de l'étude pour tous les participants est de 17 semaines.

Le critère d'évaluation principal de l'étude est l'incidence du débridement complet dans les groupes EscharEX-02 vs. Gel. Le débridement sera évalué cliniquement après chaque application (jusqu'à 8 applications en 14 jours).

Malattie studiate (Fonte di dati: BASEC)

Ulcère veineux de jambe

Health conditions (Fonte di dati: WHO)

Venous Leg Ulcer

Malattia rara (Fonte di dati: BASEC)

No

Interventi esaminati (p. es. medicamento, terapia, campagna) (Fonte di dati: BASEC)

L'intervention étudiée est l'EscharEx (formulation EX-02), une poudre qui contient un mélange d'enzymes, et qui sera mélangée avec de l'eau stérile avant l'application sur la plaie. Les enzymes ont la capacité de décomposer les tissus non-viable de la plaie, sans affecter les tissus sains. Ce processus est appelé "débridement enzymatique". Le débridement enzymatique éliminera ainsi la couche non-viable et pourrait favoriser la cicatrisation de la plaie.

Interventions (Fonte di dati: WHO)

Drug: EscharEx (5% EX-02 formulation)
Drug: Gel Vehicle
Drug: Non-surgical standard of care (NSSOC)

Criteri per la partecipazione alla sperimentazione (Fonte di dati: BASEC)

1. Patients avec un ulcère veineux de jambe et une insuffisance veineuse
2. La plaie est ouverte depuis au moins 4 semaines mais pas plus de 2 ans
3. La surface cible de la plaie est comprise entre 2-100cm^2 et la zone tissulaire non-viable représente au moins 50% de la zone de la plaie

Criteri di esclusione (Fonte di dati: BASEC)

1. La taille de la plaie a diminué de >20% après la première semaine de screening
2. Plus d'un ulcère, sur la jambe de la plaie cible, avec une surface supérieure ou égale à 2 cm^2
3. Peau gravement endommagée s'étendant à >2 cm du bord de la plaie cible et présence des signes d'une infection cliniquement significative

Inclusion/Exclusion Criteria (Fonte di dati: WHO)


Inclusion Criteria

1. Patients, men or women, between 18 and 90 years of age,

2. Patients with a VLU (determined by medical history, physical examination, and an
ultrasound scan demonstrating venous insufficiency),

3. Wound is present for at least 4 weeks but no longer than 2 years.

4. The necrotic/slough/fibrin non-viable tissue area is at least 50% of wound area
(assessed by clinical evaluation),

5. Target wound surface area is in the range of 3-100 cm2 (assessed by eKare inSightTM),

6. Patient understands the nature of the procedure, is able to adhere to the protocol
regimen, and provides a written informed consent prior to any study procedure.

Exclusion Criteria

1. Wound size decreased by > 20% after 1 week of standard-of-care-only period (screening
period),

2. Patients with more than one leg ulcer, with an area greater than or equal to 2cm2,

3. Signs of clinically significant infection including purulent discharge, deep-tissue
abscess, erysipelas, cellulitis, etc.,

4. Severely damaged skin (e.g. abrasion, exfoliation) extending >2 cm around the wound's
edge,

5. Presence of gangrene, signs of systemic infection, sepsis, or osteomyelitis during
screening phase,

6. Clinical suspicion of skin cancer (e.g. BCC, SCC, melanoma, sarcoma), which was not
ruled out by biopsy,

7. Patients with skin disorders unrelated to the wound that are presented adjacent to the
wound,

8. Patients suffering from chronic skin disorders (Idiopathic Pruritus, Psoriasis,
Panniculitis, Pyoderma Gangrenosum, etc.) that might deteriorate as a result of local
trauma or debridement,

9. Wound has sinus tracts or tunnels extending under healthy tissue (following
debridement "un-roofing"- if relevant), or penetrating into joint capsule,

10. Vascular operations in proximity to the wound in the last 3 months,

11. Patients with primary lymphatic edema,

12. A significant decrease in the arterial blood flow of the extremity

13. Patients with pre-enrolment wounds which are covered by eschar heavily saturated with
iodine or by silver sulfadiazine (SSD) pseudoeschar (i.e. pseudoeschar as a result of
SSD treatment),

14. History of allergy or atopic disease or a known sensitivity to pineapples, papaya,
bromelain or papain, as well as known sensitivity to latex proteins (known as
latex-fruit syndrome), bee venom or olive tree pollen,

15. Patients with poor nutritional status: albumin < 2.5g/dl, poorly controlled Diabetes
Mellitus (for diabetic patients; HbA1c > 11%), anemia (hemoglobin15000/µl, abnormal liver function (AST, ALT>2 x upper limit of
normal range), renal failure (Cr > 2.5 mg/dl), BMI>40,

16. Patients undergoing renal or peritoneal dialysis,

17. Any condition that would preclude safe participation in the study, e.g. evidence of
significant or unstable cardiovascular, pulmonary, liver, hematological,
immunological, or neoplastic disease, or any immediate life threatening condition,

18. Recent history (less than 6 months) of myocardial infarction (MI) or concurrent acute
injury or disease that might compromise the patient's welfare,

19. Patient is currently receiving, or has received at any time within three months prior
to enrollment, any medications or treatments known to affect the wound healing
processes; these include, chronic systemic steroid intake with topical skin changes
(i.e. thin, fragile skin with multiple heamatomas or previous laceration history)
immuno-suppressive drugs, radiation therapy, immunomodulating medications and
chemotherapy,

20. Mentally incapacitated adults who are incapable of giving legal consent (e.g.
dementia, psychiatric patients, etc.),

21. Concurrent use of non-approved drugs or alcohol abuse,

22. Pregnant women (positive pregnancy test) or nursing mothers,

23. Exposure to investigational intervention within three months prior to enrollment, or
anticipated participation in another investigational drug trial or other intervention
trial, while enrolled in the study.

Minimum age: 18 Years
Maximum age: 90 Years
Sex: All

Altri dati sulla sperimentazione nel registro primario dell’OMS

http://www.who.int/trialsearch/Trial2.aspx?TrialID=NCT03588130

Altri dati sulla sperimentazione dalla banca dati dell’OMS (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03588130

Altre informazioni sulla sperimentazione

Data di registrazione della sperimentazione

20.06.2018

Inserimento del primo partecipante

02.12.2019

Stato di reclutamento

Recruiting

Data globale di conclusione della sperimentazione

30.11.-0001

Titolo scientifico (Fonte di dati: WHO)

A Multicenter , Prospective, Randomized, Placebo Controlled, Adaptive Design Study Performed to Evaluate the Safety and the Efficacy of EscharEx (EX-02 Formulation) in Debridement of Venous Leg Ulcers

Tipo di sperimentazione (Fonte di dati: WHO)

Interventional

Disegno della sperimentazione (Fonte di dati: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).

Fase (Fonte di dati: WHO)

Phase 2

Punti finali primari (Fonte di dati: WHO)

Incidence of complete debridement in EX-02 vs. Gel Vehicle arms, scored dichotomously (yes/no), clinically assessed

Contatto per informazioni (Fonte di dati: WHO)

Please refer to primary and secondary sponsors

Risultati della sperimentazione (Fonte di dati: WHO)

Sintesi dei risultati

ancora nessuna informazione disponibile

Collegamento ai risultati nel registro primario

ancora nessuna informazione disponibile

Informazioni sulla disponibilità dei dati dei singoli partecipanti

ancora nessuna informazione disponibile

Siti di esecuzione della sperimentazione

Siti di esecuzione in Svizzera (Fonte di dati: BASEC)

Ginevra

Paesi di esecuzione (Fonte di dati: WHO)

È possibile che la Svizzera non appaia ancora come paese di esecuzione perché non è ancora stata registrata nel registro primario dell’OMS.
United States

Contatto per maggiori informazioni sulla sperimentazione

Dati della persona di contatto in Svizzera (Fonte di dati: BASEC)

GALSER SA
+41225961434
clinicaltrials@galser.ch

Contatto per informazioni generali (Fonte di dati: WHO)

Yael Katz-Levy, PhD
972546774149
yaelkl@mediwound.com

Responsabile della sperimentazione

Sponsor principale (Fonte di dati: WHO)

MediWound Ltd

Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)

Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)

Commission Cantonale d’éthique de la recherche Genève (CCER)

Data di autorizzazione da parte della commissione d’etica

29.03.2021

Altri numeri di identificazione delle sperimentazioni

Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID) (Fonte di dati: BASEC)

2020-02975

Secondary ID (Fonte di dati: WHO)

MW2017-06-28