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A Randomized, Placebo-Controlled, Double-blind, Dose-Ranging, Multicenter, Phase IIb Clinical Trial to Investigate the Efficacy and Safety of allo-APZ2-CVU on Wound Healing of Therapy-Resistant Chronic Venous Ulcer (CVU)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510162-27-00
Acronym
allo-APZ2-CVU-IIb
Enrollment
200
Registered
2024-03-06
Start date
2021-08-18
Completion date
2025-11-25
Last updated
2025-08-21

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

Conditions

Chronic venous ulcers (CVU)

Brief summary

Complete wound closure at Week 18 already persisting for at least two weeks;, Adverse events;

Detailed description

Wound size change in percent at each post-baseline follow-up visit;, Time to complete wound closure;, Complete wound closures at each post-baseline follow-up visit;, Duration of wound closure;, Recurrence of the wound;, Quality of wound healing at each post-baseline follow-up visit;, Assessment of Quality of Life using the Wound-Quality of Life Questionnaire at V8, V11, V14;, Pain assessment as per numerical rating scale on each post-baseline efficacy follow-up visit;, Physical examination and vital signs at V14.

Interventions

DRUGallo-APZ2-CVU_2
DRUGallo-APZ2-CVU_1
DRUGallo-APZ2-CVU_3
DRUGPlacebo

Sponsors

Rheacell GmbH & Co. KG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Complete wound closure at Week 18 already persisting for at least two weeks;, Adverse events;

Secondary

MeasureTime frame
Wound size change in percent at each post-baseline follow-up visit;, Time to complete wound closure;, Complete wound closures at each post-baseline follow-up visit;, Duration of wound closure;, Recurrence of the wound;, Quality of wound healing at each post-baseline follow-up visit;, Assessment of Quality of Life using the Wound-Quality of Life Questionnaire at V8, V11, V14;, Pain assessment as per numerical rating scale on each post-baseline efficacy follow-up visit;, Physical examination and vital signs at V14.

Countries

Germany

Outcome results

None listed

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