Zusammenfassende Beschreibung der Studie (Datenquelle: 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).
Untersuchte Krankheiten(Datenquelle: BASEC)
Ulcère veineux de jambe
Health conditions
(Datenquelle: WHO)
Venous Leg Ulcer
Seltene Krankheit
(Datenquelle: BASEC)
Nein
Untersuchte Intervention (z.B. Medikament, Therapie, Kampagne)
(Datenquelle: 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
(Datenquelle: WHO)
Drug: EscharEx (5% EX-02 formulation);Drug: Gel Vehicle;Drug: Non-surgical standard of care (NSSOC)
Kriterien zur Teilnahme an der Studie
(Datenquelle: 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
Ausschlusskriterien
(Datenquelle: 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
(Datenquelle: 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 2-100 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, on the leg of the target wound, 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 month,
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 > 12%), anemia (hemoglobin<8 g/dL), a leukocyte
counts < 3,800// µl or >15000/µl, platelets <100,000/µl, abnormal liver function (AST,
ALT>2 x upper limit of normal range), renal failure (Cr > 2.5 mg/dl), BMI>48,
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.
-
Weitere Informationen zur Studie
Datum der Studienregistrierung
20.06.2018
Einschluss der ersten teilnehmenden Person
02.12.2019
Rekrutierungsstatus
Completed
Wissenschaftlicher Titel
(Datenquelle: 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
Studientyp
(Datenquelle: WHO)
Interventional
Design der Studie
(Datenquelle: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase
(Datenquelle: WHO)
Phase 2
Primäre Endpunkte
(Datenquelle: WHO)
Incidence of complete debridement in EX-02 vs. Gel Vehicle arms, scored dichotomously (yes/no), clinically assessed
Kontakt für Auskünfte
(Datenquelle: WHO)
Please refer to primary and secondary sponsors
Ergebnisse der Studie
(Datenquelle: WHO)
Zusammenfassung der Ergebnisse
noch keine Angaben verfügbar
Link zu den Ergebnissen im Primärregister
noch keine Angaben verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
noch keine Angaben verfügbar
Studiendurchführungsorte
Durchführungsorte in der Schweiz
(Datenquelle: BASEC)
Genf
Durchführungsländer
(Datenquelle: WHO)
Switzerland, United States
Kontakt für weitere Auskünfte zur Studie
Angaben zur Kontaktperson in der Schweiz
(Datenquelle: BASEC)
GALSER SA
+41225961434
clinicaltrials@galser.ch
Kontakt für allgemeine Auskünfte
(Datenquelle: WHO)
Yael Katz-Levy, PhD
972546774149
yaelkl@mediwound.com
Bewilligung durch Ethikkommission (Datenquelle: BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Commission Cantonale
d’éthique de la recherche Genève (CCER)
Datum der Bewilligung durch die Ethikkommission
29.03.2021
Weitere Studienidentifikationsnummern
Studienidentifikationsnummer der Ethikkommission (BASEC-ID)
(Datenquelle: BASEC)
2020-02975
Secondary ID (Datenquelle: WHO)
MW2017-06-28
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