Venous Leg Ulcer (VLU)Phase 3VALUENCT06568627
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
A Phase 3 study testing EscharEx (EX-03) in people with Venous Leg Ulcer (VLU), run by MediWound Ltd at 60 sites in 9 countries.
Trial summary
The main objective of this study is: To assess the efficacy and safety of EscharEx (EX-03 5% formulation) compared to placebo control,in debridement and wound bed preparation of Venous Leg Ulcers (VLU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer (VLU)
- What is being tested?
- EscharEx (EX-03)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 60 sitesin 9 countries
- Study dates
- 1 Jun 2025to Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women, older than 18 years of age,
- Patients with a VLU (determined by medical history, physical examination, and a documented ultrasound scan demonstrating venous insufficiency),
- Wound is present for at least 4 weeks but no longer than 18 months,
- The adherent necrotic/thick slough/fibrin non-viable tissue area, assessed following wound cleansing with wet gauze and either sterile saline or water and mild soap, at least 50% of the wound area (assessed by clinical evaluation),
- Target wound surface area is in the range of 2-25 cm2 (assessed by eKare inSightTM),
- 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.
Who cannot join
- Wound size that has decreased by > 20% after 7 (+3/-1) days of the screening period,
- Patients with more than one leg ulcer, on the leg of the target wound, with an area greater than or equal to 2 cm2, that are between 2cm and 5cm away from the edge of the target wound,
- Signs of clinical infection of the wound or peri-wound, including purulent discharge, deep-tissue abscess, erysipelas, cellulitis, etc.,
- Severely damaged skin (e.g. abrasion, erosion, exfoliation) extending >2 cm around the wound's edge,
- Presence of gangrene, signs of systemic infection, sepsis, or osteomyelitis during screening phase,
- Clinical suspicion of skin cancer (e.g., basal cell carcinoma (BCC), squamous cell carcinoma (SCC), melanoma, or sarcoma), near the target wound, which was not ruled out by biopsy,
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- Patients with skin disorders unrelated to the wound that are presented adjacent to the wound,
- Patients suffering from chronic skin disorders (Idiopathic Pruritus, Psoriasis, Panniculitis, Pyoderma gangrenosum, etc.) that might deteriorate as a result of local trauma or debridement,
- Wound has sinus tracts or tunnels extending under healthy tissue or penetrating into periosteum, fascia or bone,
- Patients with primary lymphatic edema (Lymphedema),
- A significant decrease in the arterial blood flow of the extremity, as demonstrated by either Toe-Brachial Index (TBI) ≤ 0.50, Ankle-Brachial Index (ABI) ≤ 0.70, Skin Perfusion Pressure (SPP) ≤ 40 mmHg, Transcutaneous oximetry (TCOM) ≤ 40 mmHg, or lack of bi-phasic or tri-phasic doppler wave forms,
- Patients with pre-enrollment 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),
- History of allergy or atopic disease or a known sensitivity to pineapples, bromelain, papaya or papain, as well as known sensitivity to latex proteins (known as latex-fruit syndrome), bee venom or olive tree pollen,
- Patients with poor nutritional status: albumin < 2.5 g/dl; poorly controlled diabetes mellitus (HbA1c > 12%); anemia (hemoglobin<8 g/dL), leukocyte count < 3,000/μl or >15000/μl; neutrophil count ≤1000/μl; platelets <100,000/μl, abnormal liver function (AST, ALT>2 x upper limit of normal range), renal failure (Cr > 2.5 mg/dl or eGFR < 30ml/min /1.73m2), BMI>48,
- INR>2 or PTT > x 2 ULN (unless the patient receives coumarin derivatives anticoagulants (e.g. warfarin), and the INR and PTT levels are in their required levels and are stable),
- Patients undergoing renal or peritoneal dialysis,
- Any condition that would preclude safe participation in the study, e.g., significant or unstable cardiac, vascular, pulmonary, liver, hematological, immunological, neoplastic disease, active COVID-19 or any immediate life-threatening condition,
- Recent history or concurrent acute injury or disease that might compromise the patient's welfare, according to investigator discretion,
- The patient is currently receiving, has received within three months prior to enrollment, or is planned to receive during trial period, any medications or treatments at doses known to impair the wound healing processes. These include chronic systemic steroid intake5 associated with topical skin changes (i.e. thin, fragile skin with multiple hematomas or a history of laceration), immuno-suppressive drugs, immunomodulating medications, chemotherapy, and radiation therapy. Low and intermittent doses that the investigator determines as not clinically significant for wound healing, may be permitted, provided that this determination is based on appropriate clinical judgment and is documented accordingly,
- Patients treated with Pentoxifylline within 2 weeks prior to screening,
- Venous ablation performed within the past month in an area adjacent to the target wound,
- Mentally incapacitated incompetent adults who are incapable of giving legal consent (e.g., dementia, psychiatric patients, etc.),
- Concurrent use of non-approved drugs or alcohol abuse,
- Pregnant women (positive pregnancy test) or nursing mothers,
- Exposure to investigational intervention within one month prior to enrollment, or anticipated participation in another investigational drug trial or other intervention trial, while enrolled in the study.
Trial locations and contacts
60 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
60 sites in 9 countries
United States19 sites, 17 recruiting
- Withdrawn
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Pedro Jardim, SC, 617-414-8092, pedro.jardim@bmc.org
Emily Meng, SC, 617-414-8092, emily.meng@bmc.org
- Recruiting
Cutting Edge Research LLC.,
Circleville, Ohio, 43113
Marie Liden, 614-519-7845, researchbase969@gmail.com
Brock Liden, MD
- Not yet recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Chelsea Wynn, SC, 469-554-8592, Chelsea.Wynn@utsouthwestern.edu
Hong Li, 214-648-5485, hong.li@utsouthwestern.edu
- Recruiting
Limb Preservation Platform, Inc
Fresno, California, 93710
Destiny Blackstone, SC, (800) 714-8011, Destiny@LPPresearch.com
Shawn Cazzell, DPM
- Recruiting
Clinical Trial Network Houston
Houston, Texas, 77074
Shafae Saleem, SC, 713-484-6947, SSaleem@CTNtexas.com
Ullabritt Larka, MD
- Recruiting
Northwell Health Comprehensive Wound Healing Center
Lake Success, New York, 11042
Sally Kaplan, SC, 516-233-3780, Skaplan2@northwell.edu
Alisha Oropallo, MD
- Recruiting
Angel City Research,Inc
Los Angeles, California, 90010
Maira Jackson, SC, 213-631-0596, maira@angelcityresearch.com
Joanna Cuevas, SC, 213-365-0793, joanna@angelcityresearch.com
- Recruiting
University of Miami
Miami, Florida, 33136
Aliette Espinosa, SC, 305-689-3376, a.espinosa2@med.miami.edu
Leonela Espinoza, SC, 305-689-3376, Lte17@med.miami.edu
- Recruiting
NYU Langone Health Long Island - Research & Academic Center
Mineola, New York, 11501
Monica Benitez, SC, 516-969-6120, monica.benitez@nyulangone.org
Scott Gorenstein, MD
- Recruiting
Mount Sinai West
New York, New York, 10019
Aurora Santos, SC, 212-523-4797, aurora.santos@mountsinai.org
Garismar Ramirez, SC, 212-523-8195, garismar.ramirez@mountsinai.org
- Recruiting
Rutgers New Jersey Medical Center
Newark, New Jersey, 07103
Saharsh Patel, SC, 973-972-3173, ssp186@gsbs.rutgers.edu
Mehreen Bhatti, SC, (973) 972-5435, mb2276@njms.rutgers.edu
- Not yet recruiting
Synergy Wound 360, PLLC
Phoenix, Arizona, 85053
Tariq Khan, SC, 914-649-7872, TK@synergyhealth360.com
Vinamra Jain, MD
- Not yet recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Keeley McConnell, SC, 503-418-4877, mcconnke@ohsu.edu
Amie Lorisch, SC, lorischa@ohsu.edu
- Withdrawn
Woundcentrics, LLC
San Antonio, Texas, 78251
- Not yet recruiting
North Park Podiatry
San Diego, California, 92104
Lara Marbella
Trent Brookshier, MD
- Recruiting
Center for Clinical Research INC
San Francisco, California, 94115
Maria Peralta, SC, (800) 363-1069, maria@ccr-trials.com
Elizabeth Gofman, SC, (800) 363-1069, elizabeth@ccr-trials.com
- Recruiting
ILD Research Center
Vista, California, 92081
Eric Martinez, SC, 760-350-5080, eric@ildresearch.com
Yani Manaznares, SC, 760-350-5080, yani@ildresearch.com
- Not yet recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Angela Golding, SC, Angela.B.Golding@medstar.net
Jeffrey Shupp, MD
Poland10 sites, 9 recruiting
- Recruiting
ClinicMed Daniluk, Nowak Sp.k.
Bialystok, Odlaskie Voivodeship (Podlaskie), 15-879
Patryk Trypuc, SC, +48 601746987, trypuc@clinicmed.pl
Emilia Kowalczuk, SC, +48 601746987, kowalczuk@clinicmed.pl
- Not yet recruiting
Centrum Medyczne Ultramed
Krakow, Lesser Poland Voivodeship (Małopolskie), 30-002
Aneta Zymon, SN, aneta@zymon.net
Mikołaj Maga, MD
- Recruiting
MIKOMED Sp. z o.o.
Lodz
Aleksandra Kwapisz, SC, +48 600919797, mikomed@mikomed.pl
Jacek Mikosiński, MD
- Recruiting
Centrum Medyczne ARGO
Lodz, Łódź Voivodeship (Łódzkie), 90-212
Wojciech Fidos, SC, +48 781 347 083, w.fidos@argo-med.pl
Adam Lipiński, SC, +48 790 357 113, a.lipinski@argo-med.pl
- Not yet recruiting
ETG Poniatowa
Lublin, Lublin Voivodeship (Lubelskie), 20-223
Patrycja Barańska, SC, +48 665 927 070, p.baranska@etg-network.com
Marlena Krzyszczak, SC, +48 577 050 945, m.krzyszczak@etg-network.com
- Recruiting
Allmedica Badania Kliniczne
Nowy Targ
Marta Spytek, SC, +48 531981164, marta.spytek@allmedica.pl
Patrycja Lesnicka, SC, +48 575886613, patrycja.lesnicka@allmedica.pl
- Withdrawn
Centrum medyczne Solumed
Poznan
- Not yet recruiting
Centrum Leczenia Oparzeń
Siemianowice Śląskie, Silesian Voivodeship, 41-100
Magdalena Szatan, SC, +48 695 193 046, magdalena.szatan@clo.com.pl
Katarzyn Sommer Sommer, SC, +48 504 118 375, sommer.k@clo.com.pl
- Recruiting
Centrum Medyczne INMEDICO sp. z o.o.
Tychy, Silesian Voivodeship (Śląskie), 43-100
Mateusz Kostecki, SC, +48 513 035 475, m.kostecki@inmedico.pl
Anna Herman-Kostecka, SC, +48 501 456 235, a.kostecka@inmedico.pl
- Recruiting
Klinika PODOS
Warsaw, Masovian Voivodeship (Mazowieckie), 02-541
Anna Kołacin, SC, +48 518 389 368, a.kolacin@podos.pl
Gabriela Lubańska, SC, +48 662 051 771, g.lubanska@podos.pl
Germany7 sites, 5 recruiting
- Not yet recruiting
Helios Klinikum Berlin-Buch
Berlin, 13125
Annette Reichardt, SC, +49 30 9401-14852, annette.reichardt@helios-gesundheit.de
Annette Reichardt, SC, annette.reichardt@helios-gesundheit.de
- Recruiting
Ruhr-University Bochum
Bochum
Maren Hoffmann, SC, +49 234 8792 377, maren.hoffmann@kklbo.de
Markus Stücker, MD
- Not yet recruiting
DRK Hospital Chemnitz-Rabenstein
Chemnitz, Saxony (Sachsen), 09117
Ria Azeroth, SC, +49 371 832 1063, azeroth.ria@drk-khs.de
Michelle Funke, SC, +49 371 832 1065, funke.michelle@drk-khs.de
- Withdrawn
Städtisches Klinikum Dresden
Dresden
- Recruiting
Wundzentrum Dermatologie Erlangen
Erlangen
Loannis Sagonas, SI, +49 09131-85 35000, ioannis.sagonas@uk-erlangen.de
Cornelia Erfurt-Berge, MD
- Terminated
DermaKiel - Allergie und Haut Centrum
Kiel
- Recruiting
TUM Klinikum rechts der Isar
München, Bavaria, 81675
Marie Kristin Fritsche, SC, + 49 89 4140-6054, MarieKristin.Fritsche@mri.tum.de
Tessa Van der Kerkhof, SC, + 49 89 4140-9244, Tessa.vandeKerkhof@mri.tum.de
Israel6 sites, 6 recruiting
- Recruiting
Asaf Harofeh (Shamir) Medical Center
Be’er Ya‘aqov
Sophia Logvinenko, SC, 972-8-9778460, sophial@shamir.gov.il
Adam Altmann, SC, 972-8-9778460, Adamal@shamir.gov.il
- Not yet recruiting
Soroka Medical Center
Beersheba, Southern District, 84101
Alina Yusufov, SC, +972 508465673, alinayus@clalit.org.il
Dor Halpern, MD
- Recruiting
Galilee Medical Center
Nahariya, Northern District, 22100
Amal Shahien, SC, +972546212413, amals@gmc.gov.il
Neda Nabwani, SC, NedaK@gmc.gov.il
- Not yet recruiting
Rabin Medical Center
Petah Tikva, Central District, 49414
Anat Dagan, SC, +972525330989, Anatda1@clalit.org.il
Yehiel Hayun, MD
- Recruiting
Sheba Medical Center
Ramat Gan
Yulia Suslovets, +972 50 4389895, yuliia.suslovets@sheba.health.gov.il
Adi Yollis, 0505914762, Adi.Yoliss@sheba.health.gov.il
- Recruiting
Kaplan Medical Center
Rehovot
Yael Shaked, SC, 972-8-9441106, yaelsha@clalit.org.il
Dana Egozi, MD
Italy6 sites, 5 recruiting
- Recruiting
Ospedale Perrino Brindisi
Brindisi, Apulia, 72100
Erminio Misurale, SC, +39 347 1249040, erminio_m@hotmail.com
Michelangelo Vestita, MD
- Not yet recruiting
Ospedale Villa Scassi
Genoa, Liguria, 16149
Emanuela Grosso, MD, +39 349 4546609, emanuela.grosso@asl3.liguria.it
Giuseppe Perniciaro, MD
- Not yet recruiting
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
Naples, Campania, 80131
Antonella Spina, SN, antonella.spina@aocardarelli.it
Ilaria Mataro, MD
- Withdrawn
Ospedale Università di Padova
Padova, Veneto, 35128
- Not yet recruiting
Ospedale S. Chiara
Pisa, Tuscany (Toscana), 56126
Francesco Rizzello, SC, +39 338 5451075, f.rizzello@gmail.com
Chiara Primerano, SC
- Recruiting
Aurelia Hospital Roma
Roma, 00182
Raoul Borioni, SC, +39 330 652728, raoulborioni@alice.it
Giorgio Guarnera, MD
Romania6 sites, 6 recruiting
- Not yet recruiting
SRI ''Agrippa Ionescu'' Balotesti
Balotești, Ilfov, 077015
Laura Raducu, MD
- Not yet recruiting
Bio Terra Med
Bucharest, Bucharest Municipality, 010701
Adriana Cojocaru, SC, +40 722263347, adriana.cojocaru@bioterramed.ro
Horia Beti, MD
- Not yet recruiting
"Bagdasar-Arseni" Clinical Emergency Hospital
Bucharest, Bucharest Municipality, 041915
Oana Leulescu, MD, oana.leulescu@gmail.com
Silviu Adrian Marinescu, MD
- Not yet recruiting
"Sf. Ioan" Clinical Emergency Hospital
Bucharest, Bucharest Municipality, 042122
Daniela Teodorescu, SC, +40 723259752, dani.teodorescu@yahoo.com
Carmen Giuglea, MD
- Not yet recruiting
Spitalul Universitar de Urgență București
Bucharest, Bucharest Municipality, 050098
Ana Maria Oproiu, MD
- Not yet recruiting
Timisoara Hospital
Timișoara, Timiș County, 300723
Andreea Luciana Rata, MD
Spain3 sites, 3 recruiting
- Not yet recruiting
Hospital Clinic Barcelona
Barcelona, Catalonia, 08036
Mariana Lacentra, SC, LACENTRA@recerca.clinic.cat
Vincent Riambau, MD
- Not yet recruiting
Clínica Universidad de Navarra
Madrid, Madrid, 28022
Loreto Rubio Nuñez, SC, lrubio@unav.es
Ignacio Leal Lorenzo, MD
- Not yet recruiting
Clínica Universidad de Navarra
Pamplona, Navarre, 31008
Raquel Valencia Dronda, SC
Bernardo Hontanilla, MD
Austria2 sites, 2 recruiting
- Recruiting
Medical University of Graz
Graz, 8036
Birgit Michelitsch, SC, +43 316 385 31957, birgit.michelitsch@medunigraz.at
Ana Villa Garcia, SC, +43 6763406026, ana.villa-garcia@medunigraz.at
- Recruiting
Medical University Wien
Vienna, 1090
Anna Fast, MD, +43 1 40400 69860, anna.fast@meduniwien.ac.at
Eva Placheta- Gyori, +43 1 40400 6986, eva.placheta-gyoeri@meduniwien.ac.at
Canada1 site, 1 recruiting
- Not yet recruiting
Scarborough Health Network
Thornhill, Ontario (ON), M1E 4B9
Lauren Sudac, SC, lsudac@shn.ca
Jonathan Hummel, MD
About this study
Official title: A Multicenter, Prospective, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of Venous Leg Ulcers (VALUE)
The main objective of this study is:
To assess the efficacy and safety of EscharEx (EX-03 5% formulation) compared to placebo control,in debridement and wound bed preparation of Venous Leg Ulcers (VLU).
Read the detailed description
At least 216 eligible adult patients with VLU (with a surface area between 2 cm2 and 25 cm2, and wound age between 4 weeks and 12 months), will be randomized. The patients will be treated with IMP (either EX-03 5% or placebo) in a double blinded manner.
Total duration of the study is up to 29 weeks:
- Screening period (2 visits, 7 days apart),
- Daily Visits Period - Debridement with IMP (up to 8 daily site visits within up to 2 weeks),
- Weekly Visits Period - wound management (up to 13 visits within up to 12 weeks) + optional wound closure confirmation (up to 2 weeks). Wound will be managed in a standardized manner.
- Monthly Visits Period - Wound Closure Durability Period of 12 weeks starting after wound closure confirmation (3 visits within 12 weeks) performed for all wounds.
- Conditions
- Venous Leg Ulcer (VLU)
- Being tested
- EscharEx (EX-03), Placebo (Gel vehicle)
- Keywords
- VLU, EscharEx, Debridement, Wound bed preparation
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscharEx (EX-03)Drug
Also called EX-03
a sterile lyophilized powder containing a concentrate of proteolytic enzymes enriched in bromelain (anacaulase-bcdb). The powder and sterile water are mixed to form a gel prior to application on the wound area.
Placebo (Gel vehicle)Drug
Also called Gel vehicle
A sterile powder containing excipients only (no proteolytic enzymes). The powder and sterile water are mixed to form a gel prior to application on the wound area
| Study group | Role | What they receive |
|---|---|---|
| EscharEx (EX-03) | Active comparator | EX-03 is the code name of the third generation of EscharEx investigational medicinal product (IMP) formulation. A sterile lyophilized powder containing a concentrate of proteolytic enzymes enriched in bromelain (anacaulase-bcdb ), the active pharmaceutical ingredient (API), that is blended with excipients.
EX-03 5% powder, should be diluted with Water for Injection (WFI) prior usage. Receives: Drug: EscharEx (EX-03) |
| Placebo | Placebo comparator | Placebo (Gel Vehicle, hydrogel) contains the same excipients as in EX-03, without the API.
Placebo powder, should be diluted with Water for Injection (WFI) prior usage. Receives: Drug: Placebo (Gel vehicle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complete debridement, clinically (visually) assessed after each application
counting events of complete debridement
Measured: up to 2 weeks
Facilitation of wound closure, clinically assessed, as measured by time to complete wound closure
counting events of complete wound closure until completion of weekly visits
Measured: up to 12 weeks
Secondary outcomes (4)
Incidence of complete healthy viable granulation tissue, as assessed clinically
counting events of complete granulation
Measured: up to 2 weeks
Time to the first declaration of complete debridement, clinically assessed
count in days
Measured: up to 12 weeks
Time to Wound Bed Prepared, clinically assessed
Number of events counted in days
Measured: up to 12 weeks
Incidence of complete wound closure, clinically assessed,
count of number of events
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start1 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg Ulcer (VLU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, prospective, randomized, double blind, placebo controlled, adaptive design study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediWound Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568627
- Sponsor's protocol ID
- MW2022-06-22
- Acronym
- VALUE
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of Venous Leg Ulcers (VALUE)
- ClinicalTrials.gov ID
- NCT06568627
- Acronym / sponsor ID
- VALUE / MW2022-06-22
- Conditions
- Venous Leg Ulcer (VLU)
- Keywords
- VLU, EscharEx, Debridement, Wound bed preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- MediWound LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is:
To assess the efficacy and safety of EscharEx (EX-03 5% formulation) compared to placebo control,in debridement and wound bed preparation of Venous Leg Ulcers (VLU).
Detailed description
At least 216 eligible adult patients with VLU (with a surface area between 2 cm2 and 25 cm2, and wound age between 4 weeks and 12 months), will be randomized. The patients will be treated with IMP (either EX-03 5% or placebo) in a double blinded manner.
Total duration of the study is up to 29 weeks:
- Screening period (2 visits, 7 days apart),
- Daily Visits Period - Debridement with IMP (up to 8 daily site visits within up to 2 weeks),
- Weekly Visits Period - wound management (up to 13 visits within up to 12 weeks) + optional wound closure confirmation (up to 2 weeks). Wound will be managed in a standardized manner.
- Monthly Visits Period - Wound Closure Durability Period of 12 weeks starting after wound closure confirmation (3 visits within 12 weeks) performed for all wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A multicenter, prospective, randomized, double blind, placebo controlled, adaptive design study.
| Arm | Type | Receives |
|---|---|---|
| EscharEx (EX-03) | Active comparator | Drug: EscharEx (EX-03)EX-03 is the code name of the third generation of EscharEx investigational medicinal product (IMP) formulation. A sterile lyophilized powder containing a concentrate of proteolytic enzymes enriched in bromelain (anacaulase-bcdb ), the active pharmaceutical ingredient (API), that is blended with excipients. EX-03 5% powder, should be diluted with Water for Injection (WFI) prior usage. |
| Placebo | Placebo comparator | Drug: Placebo (Gel vehicle)Placebo (Gel Vehicle, hydrogel) contains the same excipients as in EX-03, without the API. Placebo powder, should be diluted with Water for Injection (WFI) prior usage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women, older than 18 years of age,
- Patients with a VLU (determined by medical history, physical examination, and a documented ultrasound scan demonstrating venous insufficiency),
- Wound is present for at least 4 weeks but no longer than 18 months,
- The adherent necrotic/thick slough/fibrin non-viable tissue area, assessed following wound cleansing with wet gauze and either sterile saline or water and mild soap, at least 50% of the wound area (assessed by clinical evaluation),
- Target wound surface area is in the range of 2-25 cm2 (assessed by eKare inSightTM),
Key exclusion criteria (25 listed)
- Wound size that has decreased by > 20% after 7 (+3/-1) days of the screening period,
- Patients with more than one leg ulcer, on the leg of the target wound, with an area greater than or equal to 2 cm2, that are between 2cm and 5cm away from the edge of the target wound,
- Signs of clinical infection of the wound or peri-wound, including purulent discharge, deep-tissue abscess, erysipelas, cellulitis, etc.,
- Severely damaged skin (e.g. abrasion, erosion, exfoliation) extending >2 cm around the wound's edge,
- Presence of gangrene, signs of systemic infection, sepsis, or osteomyelitis during screening phase,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscharEx (EX-03)Also: EX-03a sterile lyophilized powder containing a concentrate of proteolytic enzymes enriched in bromelain (anacaulase-bcdb). The powder and sterile water are mixed to form a gel prior to application on the wound area. | Drug | EscharEx (EX-03) |
| Placebo (Gel vehicle)Also: Gel vehicleA sterile powder containing excipients only (no proteolytic enzymes). The powder and sterile water are mixed to form a gel prior to application on the wound area | Drug | Placebo |
Primary outcome
Incidence of complete debridement, clinically (visually) assessed after each application
Time frame: up to 2 weeks
counting events of complete debridement
Facilitation of wound closure, clinically assessed, as measured by time to complete wound closure
Time frame: up to 12 weeks
counting events of complete wound closure until completion of weekly visits
4 secondary outcomes
Incidence of complete healthy viable granulation tissue, as assessed clinically
Time frame: up to 2 weeks
Time to the first declaration of complete debridement, clinically assessed
Time frame: up to 12 weeks
Time to Wound Bed Prepared, clinically assessed
Time frame: up to 12 weeks
Incidence of complete wound closure, clinically assessed,
Time frame: up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
60 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EscharEx (EX-03) in people with Venous Leg Ulcer (VLU), run by MediWound Ltd at 60 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Poland, Germany, Israel, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yael Katz-levy, Ph.D. (+972-546774149, yaelk@mediwound.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complete debridement, clinically (visually) assessed after each application (time frame: up to 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.