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A multicenter, prospective, randomized, placebo and non-surgical standard of care (NSSOC) controlled study, performed to evaluate the safety and efficacy of EscharEx and its placebo (gel vehicle) compared to NSSOC in participants with Venous Leg Ulcers (VLU)

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526070-16-00
Enrollment
35
Registered
2026-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Leg Ulcer (VLU)

Brief summary

1. Incidence and severity of systemic and local adverse events (AEs) throughout the trial,, 2. Clinically significant changes in vital signs and clinical laboratory parameters (blood chemistry, hematology, coagulation) during the daily period,, 3. Incidence of discontinuation due to adverse reaction during the daily period,, 4. Pain, as assessed by Numeric Pain Rating Scale (NPRS), until the end of the weekly visits period,, 5. Time to complete wound closure from the initiation of study treatment, throughout the trial,, 6. Incidence of complete wound closure, throughout the trial,, 7. Percent change in wound area, from baseline until the end of the Weekly Visits Period, as assessed by eKare inSightTM.

Detailed description

1. Incidence of complete debridement, clinically (visually) assessed during the Daily Visits Period (up to 8 applications),, 2. Incidence of complete healthy viable granulation tissue, at the end of the Daily Visits Period, as assessed clinically,, 3. Time to the first declaration of complete debridement, from the initiation of study treatment throughout the trial,

Interventions

DRUGPlacebo (Gel vehicle) sterile powder: Excipients only (Lactose
DRUGpotassium phosphate dibasic
DRUGpotassium phosphate monobasic and Guar Gum)
DRUG4g

Sponsors

Mediwound Ltd.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Incidence and severity of systemic and local adverse events (AEs) throughout the trial,, 2. Clinically significant changes in vital signs and clinical laboratory parameters (blood chemistry, hematology, coagulation) during the daily period,, 3. Incidence of discontinuation due to adverse reaction during the daily period,, 4. Pain, as assessed by Numeric Pain Rating Scale (NPRS), until the end of the weekly visits period,, 5. Time to complete wound closure from the initiation of study treatment, throughout the trial,, 6. Incidence of complete wound closure, throughout the trial,, 7. Percent change in wound area, from baseline until the end of the Weekly Visits Period, as assessed by eKare inSightTM.

Secondary

MeasureTime frame
1. Incidence of complete debridement, clinically (visually) assessed during the Daily Visits Period (up to 8 applications),, 2. Incidence of complete healthy viable granulation tissue, at the end of the Daily Visits Period, as assessed clinically,, 3. Time to the first declaration of complete debridement, from the initiation of study treatment throughout the trial,

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 5, 2026