Pineapple enzyme gel could speed healing of stubborn leg wounds

NCT ID NCT06568627

Disease control Sponsor: MediWound Ltd Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Aug 25, 2026 · Updated 3 times

Summary

This study tests a gel called EscharEx, made from pineapple enzymes, to remove dead tissue from hard-to-heal leg ulcers. About 216 adults with venous leg ulcers will receive either the active gel or a placebo. The goal is to see if the gel safely and effectively cleans the wound and helps it close.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: EscharEx (a gel made from pineapple enzymes that dissolves dead tissue)
What this could lead to: If it works, this could provide a faster, less painful way to clean leg ulcers and help them heal.
What could go wrong: This is a Phase 3 trial, but results are not yet known. The gel may not work better than placebo, and some people may have skin irritation or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 216 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Men or women, older than 18 years of age, 2. Patients with a VLU (determined by medical history, physical examination, and a documented ultrasound scan demonstrating venous insufficiency), 3. Wound is present for at least 4 weeks but no longer than 18 months, 4. 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), 5. Target wound surface area is in the range of 2-25 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 that has decreased by \> 20% after 7 (+3/-1) days of the 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 2 cm2, that are between 2cm and 5cm away from the edge of the target wound, 3. Signs of clinical infection of the wound or peri-wound, including purulent discharge, deep-tissue abscess, erysipelas, cellulitis, etc., 4. Severely damaged skin (e.g. abrasion, erosion, 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., basal cell carcinoma (BCC), squamous cell carcinoma (SCC), melanoma, or sarcoma), near the target wound, 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 or penetrating into periosteum, fascia or bone, 10. Patients with primary lymphatic edema (Lymphedema), 11. 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, 12. 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), 13. 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, 14. 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, 15. 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), 16. Patients undergoing renal or peritoneal dialysis, 17. 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, 18. Recent history or concurrent acute injury or disease that might compromise the patient's welfare, according to investigator discretion, 19. 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, 20. Patients treated with Pentoxifylline within 2 weeks prior to screening, 21. Venous ablation performed within the past month in an area adjacent to the target wound, 22. Mentally incapacitated incompetent adults who are incapable of giving legal consent (e.g., dementia, psychiatric patients, etc.), 23. Concurrent use of non-approved drugs or alcohol abuse, 24. Pregnant women (positive pregnancy test) or nursing mothers, 25. 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.

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Conditions

The condition(s) this trial relates to.

ulcer of lower limbs Varicose Ulcer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Venous leg ulcer (VLU)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

58 sites in 9 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Locations

"Bagdasar-Arseni" Clinical Emergency Hospital
NOT_YET_RECRUITING

Bucharest, Bucharest Municipality, 041915, Romania
"Sf. Ioan" Clinical Emergency Hospital
NOT_YET_RECRUITING

Bucharest, Bucharest Municipality, 042122, Romania
Allmedica Badania Kliniczne
RECRUITING

Nowy Targ, Poland
Angel City Research,Inc
RECRUITING

Los Angeles, California, 90010, United States
Asaf Harofeh (Shamir) Medical Center
RECRUITING

Be’er Ya‘aqov, Israel
Aurelia Hospital Roma
RECRUITING

Roma, 00182, Italy
Azienda Ospedaliera di Modena
NOT_YET_RECRUITING

Berlin, 13125, Germany
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
NOT_YET_RECRUITING

Naples, Campania, 80131, Italy
Bio Terra Med
NOT_YET_RECRUITING

Bucharest, Bucharest Municipality, 010701, Romania
Boston Medical Center
RECRUITING

Boston, Massachusetts, 02118, United States
Center for Clinical Research INC
RECRUITING

San Francisco, California, 94115, United States
Centrum Leczenia Oparzeń
NOT_YET_RECRUITING

Siemianowice Śląskie, Silesian Voivodeship, 41-100, Poland
Centrum Medyczne ARGO
RECRUITING

Lodz, Łódź Voivodeship (Łódzkie), 90-212, Poland
Centrum Medyczne INMEDICO sp. z o.o.
RECRUITING

Tychy, Silesian Voivodeship (Śląskie), 43-100, Poland
Centrum Medyczne Ultramed
NOT_YET_RECRUITING

Krakow, Lesser Poland Voivodeship (Małopolskie), 30-002, Poland
Centrum medyczne Solumed
WITHDRAWN

Poznan, Poland
ClinicMed Daniluk, Nowak Sp.k.
RECRUITING

Bialystok, Odlaskie Voivodeship (Podlaskie), 15-879, Poland
Clinical Trial Network Houston
RECRUITING

Houston, Texas, 77074, United States
Clínica Universidad de Navarra
NOT_YET_RECRUITING

Madrid, Madrid, 28022, Spain
Clínica Universidad de Navarra
NOT_YET_RECRUITING

Pamplona, Navarre, 31008, Spain
Cutting Edge Research LLC.,
RECRUITING

Circleville, Ohio, 43113, United States

Contact Email: •••••@•••••
DRK Hospital Chemnitz-Rabenstein
NOT_YET_RECRUITING

Chemnitz, Saxony (Sachsen), 09117, Germany
DermaKiel - Allergie und Haut Centrum
RECRUITING

Kiel, Germany
ETG Poniatowa
NOT_YET_RECRUITING

Lublin, Lublin Voivodeship (Lubelskie), 20-223, Poland
Galilee Medical Center
RECRUITING

Nahariya, Northern District, 22100, Israel
Helios Klinikum Berlin-Buch
NOT_YET_RECRUITING

Berlin, 13125, Germany
Hospital Clinic Barcelona
NOT_YET_RECRUITING

Barcelona, Catalonia, 08036, Spain
ILD Research Center
RECRUITING

Vista, California, 92081, United States
Kaplan Medical Center
RECRUITING

Rehovot, Israel
Klinika PODOS
RECRUITING

Warsaw, Masovian Voivodeship (Mazowieckie), 02-541, Poland
Limb Preservation Platform LLC
WITHDRAWN

San Antonio, Texas, 78229, United States
Limb Preservation Platform, Inc
RECRUITING

Fresno, California, 93710, United States
MIKOMED Sp. z o.o.
RECRUITING

Lodz, Poland
Massachusetts General Hospital
WITHDRAWN

Boston, Massachusetts, 02114, United States
MedStar Washington Hospital Center
NOT_YET_RECRUITING

Washington D.C., District of Columbia, 20010, United States
Medical University Wien
RECRUITING

Vienna, 1090, Austria
Medical University of Graz
RECRUITING

Graz, 8036, Austria
Mount Sinai West
RECRUITING

New York, New York, 10019, United States
NYU Langone Health Long Island - Research & Academic Center
RECRUITING

Mineola, New York, 11501, United States
North Park Podiatry
NOT_YET_RECRUITING

San Diego, California, 92104, United States
Northwell Health Comprehensive Wound Healing Center
RECRUITING

Lake Success, New York, 11042, United States
Oregon Health & Science University
NOT_YET_RECRUITING

Portland, Oregon, 97239, United States
Ospedale Perrino Brindisi
RECRUITING

Brindisi, Apulia, 72100, Italy
Ospedale S. Chiara
NOT_YET_RECRUITING

Pisa, Tuscany (Toscana), 56126, Italy
Ospedale Università di Padova
NOT_YET_RECRUITING

Padova, Veneto, 35128, Italy
Ospedale Villa Scassi
NOT_YET_RECRUITING

Genoa, Liguria, 16149, Italy
Rabin Medical Center
NOT_YET_RECRUITING

Petah Tikva, Central District, 49414, Israel
Ruhr-University Bochum
RECRUITING

Bochum, Germany
Rutgers New Jersey Medical Center
RECRUITING

Newark, New Jersey, 07103, United States
SRI ''Agrippa Ionescu'' Balotesti
NOT_YET_RECRUITING

Balotești, Ilfov, 077015, Romania
Scarborough Health Network
NOT_YET_RECRUITING

Thornhill, Ontario (ON), M1E 4B9, Canada
Sheba Medical Center
RECRUITING

Ramat Gan, Israel
Soroka Medical Center
NOT_YET_RECRUITING

Beersheba, Southern District, 84101, Israel
Spitalul Universitar de Urgență București
NOT_YET_RECRUITING

Bucharest, Bucharest Municipality, 050098, Romania
Städtisches Klinikum Dresden
RECRUITING

Dresden, Germany
Synergy Wound 360, PLLC
NOT_YET_RECRUITING

Phoenix, Arizona, 85053, United States
TUM Klinikum rechts der Isar
RECRUITING

München, Bavaria, 81675, Germany
Timisoara Hospital
NOT_YET_RECRUITING

Timișoara, Timiș County, 300723, Romania
University of Miami
RECRUITING

Miami, Florida, 33136, United States
University of Texas Southwestern Medical Center
NOT_YET_RECRUITING

Dallas, Texas, 75390, United States
Woundcentrics, LLC
WITHDRAWN

San Antonio, Texas, 78251, United States
Wundzentrum Dermatologie Erlangen
RECRUITING

Erlangen, Germany

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