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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

Data source: BASEC (Imported from 27.01.2022), WHO (Imported from 18.01.2022)
Changed: 19.10.2021
Disease category: Arterial and venous diseases including deep venous thrombosis and lung embolism

Brief description of trial (Data source: 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).

Health conditions investigated (Data source: BASEC)

Ulcère veineux de jambe

Health conditions (Data source: WHO)

Venous Leg Ulcer

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: 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 (Data source: WHO)

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

Criteria for participation in trial (Data source: 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

Exclusion criteria (Data source: 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 (Data source: 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

Further information on the trial in WHO primary registry

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

Further information on the trial from WHO database (ICTRP)

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

Further information on trial

Date trial registered

20.06.2018

Incorporation of the first participant

02.12.2019

Recruitment status

Recruiting

Global completion date of trial

30.11.-0001

Academic title (Data source: 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

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

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

Phase (Data source: WHO)

Phase 2

Primary end point (Data source: WHO)

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

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Geneva

Countries (Data source: WHO)

Switzerland might not appear as site of trial if it has not yet been entered as such in the WHO primary registry.
United States

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

GALSER SA
+41225961434
clinicaltrials@galser.ch

Contact for general information (Data source: WHO)

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

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

MediWound Ltd

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

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

Date of authorisation by the ethics committee

29.03.2021

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2020-02975

Secondary ID (Data source: WHO)

MW2017-06-28