Not Yet RecruitingPhase 2

An Open Label, Single Treatment, Single Arm, Multiple Dose Phase-2 Study to Evaluate the Pharmacokinetics, Safety, and Clinical Performance of EscharEx (EX-03) in Participants With Venous Leg Ulcers

20 participantsStarted 2026-08

Plain-language summary

This is a pharmacokinetics (PK) study - the main objective of this study is to assess the PK, safety and clinical performance of 5% EscharEx (EX-03 formulation) in debridement of Venous Leg Ulcers

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Men or women, older than 18 years of age,
. Participants 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 2 years,
. 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, is at least 50% of the wound area (assessed by clinical evaluation),
. Target wound surface area is in the range of 10-80 cm2 (assessed by eKare inSightTM),
. Participants understand the nature of the procedure, is able to adhere to the protocol regimen, and provides written informed consent prior to any study procedure.

Exclusion criteria

. Wound size that has decreased by \> 20% after 7 (+3/-1) days of the screening period,
. Participants 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 2 cm and 5 cm away from the edge of the target wound,
. Severely damaged skin (e.g., abrasion, erosion, exfoliation) extending \>2 cm around the wound's edge,

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PK Evaluation

Timeframe: Up to 2 weeks

Safety and Tolerability Endpoints

Timeframe: up to 5 weeks

PK Evaluation

Timeframe: Up to 2 weeks

Trial details

NCT IDNCT07692178

SponsorMediWound Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-08

Contact for this trial

Shelly Vander

+972-523527960 shellyv@mediwound.com

View on ClinicalTrials.gov More Venous Leg Ulcer (VLU) trials