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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)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519623-23-00
Acronym
MW2022-06-22
Enrollment
96
Registered
2025-06-11
Start date
2025-10-20
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Venous leg ulcer

Brief summary

Incidence of complete debridement, clinically (visually) assessed after each application during the Daily Visits Period (up to 8 applications),, Incidence of complete wound closure, clinically assessed from the initiation of study treatment until the end of the Weekly Visits Period.

Detailed description

Incidence of complete healthy viable granulation tissue, at the end of the Daily Visits Period, as assessed clinically, Time to the first declaration of complete debridement, clinically assessed, from the initiation of study treatment until the end of the Weekly Visits Period, Time to complete wound closure, clinically assessed, from the initiation of study treatment, until the end of the Weekly Visits Period

Interventions

DRUGAmnion/Chorion Membrane Allograft

Sponsors

Mediwound Ltd.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence of complete debridement, clinically (visually) assessed after each application during the Daily Visits Period (up to 8 applications),, Incidence of complete wound closure, clinically assessed from the initiation of study treatment until the end of the Weekly Visits Period.

Secondary

MeasureTime frame
Incidence of complete healthy viable granulation tissue, at the end of the Daily Visits Period, as assessed clinically, Time to the first declaration of complete debridement, clinically assessed, from the initiation of study treatment until the end of the Weekly Visits Period, Time to complete wound closure, clinically assessed, from the initiation of study treatment, until the end of the Weekly Visits Period

Countries

Austria, Germany, Italy, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026