MedTrace Logo

Clinical Trial to Investigate Efficacy and Safety of the IMP in Patients With Non Healing Wounds Originating From Ulcers

NCT02742844 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-07-07

No results posted yet for this study

Summary

The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction) and safety (by monitoring occurring adverse events) of the investigational medicinal product APZ2 after one single application on chronic venous leg ulcer wounds.

Conditions

  • Skin Ulcer Venous Stasis Chronic

Interventions

BIOLOGICAL

APZ2 application

Application of IMP on patients wound.

Sponsors & Collaborators

  • Ticeba GmbH

    collaborator INDUSTRY

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • Granzer Regulatory Consulting & Services

    collaborator OTHER

  • RHEACELL GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Andreas Kerstan, PD Dr.med. · Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Würzburg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2019-01-15
Completion
2019-01-15

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02742844 on ClinicalTrials.gov